Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Intravenous iron in patients with heart failure and reduced ejection fraction (HFREF) plus iron deficiency: Effects upon phosphate and FGF23 metabolism

    Summary
    EudraCT number
    		 2016-004147-37
    Trial protocol
    		 DE  
    Global end of trial date
    25 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2022
    First version publication date
    19 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    16-047
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Center for Translational & Clinical Research Aachen (CTC-A)
    Sponsor organisation address
    Pauwelsstraße 30, Aachen, Germany, 52074
    Public contact
    Center for Translational & Clinical Research Aachen (CTC-A), Universitätsklinikum RWTH Aachen, 0049 2418080092, ctc-a-spoqs@ukaachen.de
    Scientific contact
    Center for Translational & Clinical Research Aachen (CTC-A), Universitätsklinikum RWTH Aachen, 0049 2418080092, ctc-a-spoqs@ukaachen.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up (“main”) study.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    12
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment and treatment of subjects was performed in one trial center. Overall 23 subjects were enrolled and randomized in the clinical trial in the timeframe from 13.03.2017 till 25.10.2017.

    Pre-assignment
    Screening details
    		 Overall 51 subjects were screened in one trial center. Of those 51 subjects screened, 23 subjects met the inclusion and exclusion criteria and were enrolled.

    Period 1
    Period 1 title
    Day 0 pre-infusion
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Arm title
    		 Non Chronic Kidney Disease
    Arm description
    		 Non Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Number of subjects in period 1
    		Chronic Kidney Disease Non Chronic Kidney Disease
    Started
    12
    11
    Completed
    12
    11
    Period 2
    Period 2 title
    Day 0 post-infusion
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Arm title
    		 Non Chronic Kidney Disease
    Arm description
    		 Non Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Number of subjects in period 2
    		Chronic Kidney Disease Non Chronic Kidney Disease
    Started
    12
    11
    Completed
    12
    11
    Period 3
    Period 3 title
    Day 1
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Arm title
    		 Non Chronic Kidney Disease
    Arm description
    		 Non Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Number of subjects in period 3
    		Chronic Kidney Disease Non Chronic Kidney Disease
    Started
    12
    11
    Completed
    12
    11
    Period 4
    Period 4 title
    Day 7
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Arm title
    		 Non Chronic Kidney Disease
    Arm description
    		 Non Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Number of subjects in period 4
    		Chronic Kidney Disease Non Chronic Kidney Disease
    Started
    12
    11
    Completed
    12
    11
    Period 5
    Period 5 title
    Day 14
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Arm title
    		 Non Chronic Kidney Disease
    Arm description
    		 Non Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Number of subjects in period 5
    		Chronic Kidney Disease Non Chronic Kidney Disease
    Started
    12
    11
    Completed
    12
    11
    Period 6
    Period 6 title
    Day 28
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Arm title
    		 Non Chronic Kidney Disease
    Arm description
    		 Non Chronic Kidney Disease
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron(III) carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of 1000 mg Iron(III)-carboxymaltose (Ferrinject) via intravenous injection

    Number of subjects in period 6
    		Chronic Kidney Disease Non Chronic Kidney Disease
    Started
    12
    11
    Completed
    12
    11

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Day 0 pre-infusion
    Reporting group description
    		 -

    Reporting group values
    		 Day 0 pre-infusion Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.7 ± 12.26 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 12 12

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 Chronic Kidney Disease

    Reporting group title
    Non Chronic Kidney Disease
    Reporting group description
    		 Non Chronic Kidney Disease
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 Chronic Kidney Disease

    Reporting group title
    Non Chronic Kidney Disease
    Reporting group description
    		 Non Chronic Kidney Disease
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 Chronic Kidney Disease

    Reporting group title
    Non Chronic Kidney Disease
    Reporting group description
    		 Non Chronic Kidney Disease
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 Chronic Kidney Disease

    Reporting group title
    Non Chronic Kidney Disease
    Reporting group description
    		 Non Chronic Kidney Disease
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 Chronic Kidney Disease

    Reporting group title
    Non Chronic Kidney Disease
    Reporting group description
    		 Non Chronic Kidney Disease
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 Chronic Kidney Disease

    Reporting group title
    Non Chronic Kidney Disease
    Reporting group description
    		 Non Chronic Kidney Disease

    Subject analysis set title
    Baseline CKD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with chronic kidney disease at baseline

    Subject analysis set title
    Baseline non-CKD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients without chronic kidney disease at baseline.

    Primary: intact FGF23 (iFGF23) - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 intact FGF23 (iFGF23) - Day 0 pre-infusion
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    12
    11
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    214.2 ± 188.6
    17.28 ± 11.01
    214.2 ± 188.6
    17.28 ± 11.01
    Statistical analysis title
    		 Analysis iFGF23-CKD - Day 0 pre-infusion
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis iFGF23-non-CKD - Day 0 pre-infusion
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: intact FGF23 (iFGF23) - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 intact FGF23 (iFGF23) - Day 0 post-infusion
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    12
    11
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    228.4 ± 210.1
    10.64 ± 11.85
    214.2 ± 188.6
    17.28 ± 11.01
    Statistical analysis title
    		 Analysis iFGF23-CKD - Day 0 post-infusion
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis iFGF23-non-CKD - Day 0 post-infusion
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: intact FGF23 (iFGF23) - Day 1

    		 Close Top of page
    End point title
    		 intact FGF23 (iFGF23) - Day 1
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    12
    11
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    384.6 ± 316.2
    178.9 ± 131.6
    214.2 ± 188.6
    17.28 ± 11.01
    Statistical analysis title
    		 Analysis iFGF23-CKD - Day 1
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis iFGF23-non-CKD - Day 1
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: intact FGF23 (iFGF23) - Day 7

    		 Close Top of page
    End point title
    		 intact FGF23 (iFGF23) - Day 7
    End point description
    End point type
    Primary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    11 [1]
    11
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    289.7 ± 335.3
    126.5 ± 80.46
    214.2 ± 188.6
    17.28 ± 11.01
    Notes
    [1] - 1 missing data
    Statistical analysis title
    		 Analysis iFGF23-CKD - Day 7
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis iFGF23-non-CKD - Day 7
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: intact FGF23 (iFGF23) - Day 14

    		 Close Top of page
    End point title
    		 intact FGF23 (iFGF23) - Day 14
    End point description
    End point type
    Primary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    9 [2]
    10 [3]
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    222.7 ± 168.75
    65.9 ± 56.03
    214.2 ± 188.6
    17.28 ± 11.01
    Notes
    [2] - 3 missing data
    [3] - 1 missing data
    Statistical analysis title
    		 Analysis iFGF23-CKD - Day 14
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis iFGF23-non-CKD - Day 14
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: intact FGF23 (iFGF23) - Day 28

    		 Close Top of page
    End point title
    		 intact FGF23 (iFGF23) - Day 28
    End point description
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    10 [4]
    10 [5]
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    169.03 ± 176.32
    24.53 ± 23.45
    214.2 ± 188.6
    17.28 ± 11.01
    Notes
    [4] - 2 missing data
    [5] - 1 missing data
    Statistical analysis title
    		 Analysis iFGF23-CKD - Day 28
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis iFGF23-non-CKD - Day 28
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: c-term FGF23 (cFGF23) - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 c-term FGF23 (cFGF23) - Day 0 pre-infusion
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    11 [6]
    11
    11 [7]
    11
    Units: RU / ml
        arithmetic mean (standard deviation)
    805.6 ± 535.8
    302.5 ± 464.8
    805.6 ± 535.8
    302.5 ± 464.8
    Notes
    [6] - 1 missing data
    [7] - 1 missing data
    Statistical analysis title
    		 Analysis cFGF23-CKD - Day 0 pre-infusion
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis cFGF23-non-CKD - Day 0 pre-infusion
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: c-term FGF23 (cFGF23) - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 c-term FGF23 (cFGF23) - Day 0 post-infusion
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    11 [8]
    11
    11 [9]
    11
    Units: RU / ml
        arithmetic mean (standard deviation)
    751.1 ± 493.2
    329.9 ± 501.5
    805.6 ± 535.8
    302.5 ± 464.8
    Notes
    [8] - 1 missing data
    [9] - 1 missing data
    Statistical analysis title
    		 Analysis cFGF23-CKD - Day 0 post-infusion
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis cFGF23-non-CKD - Day 0 post-infusion
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: c-term FGF23 (cFGF23) - Day 1

    		 Close Top of page
    End point title
    		 c-term FGF23 (cFGF23) - Day 1
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    11 [10]
    11
    11 [11]
    11
    Units: RU / ml
        arithmetic mean (standard deviation)
    756.8 ± 515.9
    342.1 ± 424.2
    805.6 ± 535.8
    302.5 ± 464.8
    Notes
    [10] - 1 missing data
    [11] - 1 missing data
    Statistical analysis title
    		 Analysis cFGF23-CKD - Day 1
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis cFGF23-non-CKD - Day 1
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: c-term FGF23 (cFGF23) - Day 7

    		 Close Top of page
    End point title
    		 c-term FGF23 (cFGF23) - Day 7
    End point description
    End point type
    Primary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    10 [12]
    11
    11 [13]
    11
    Units: RU / ml
        arithmetic mean (standard deviation)
    693.7 ± 499.1
    178.2 ± 154.4
    805.6 ± 535.8
    302.5 ± 464.8
    Notes
    [12] - 2 missing data
    [13] - 1 missing data
    Statistical analysis title
    		 Analysis cFGF23-CKD - Day 7
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis cFGF23-non-CKD - Day 7
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: c-term FGF23 (cFGF23) - Day 14

    		 Close Top of page
    End point title
    		 c-term FGF23 (cFGF23) - Day 14
    End point description
    End point type
    Primary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    9 [14]
    10 [15]
    11 [16]
    11
    Units: RU / ml
        arithmetic mean (standard deviation)
    605.4 ± 486.11
    83.5 ± 36.12
    805.6 ± 535.8
    302.5 ± 464.8
    Notes
    [14] - 3 missing data
    [15] - 1 missing data
    [16] - 1 missing data
    Statistical analysis title
    		 Analysis cFGF23-CKD - Day 14
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis cFGF23-non-CKD - Day 14
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval

    Primary: c-term FGF23 (cFGF23) - Day 28

    		 Close Top of page
    End point title
    		 c-term FGF23 (cFGF23) - Day 28
    End point description
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease Baseline CKD Baseline non-CKD
    Number of subjects analysed
    10 [17]
    10 [18]
    11 [19]
    11
    Units: RU / ml
        arithmetic mean (standard deviation)
    452.94 ± 403.14
    82.29 ± 99.66
    805.6 ± 535.8
    302.5 ± 464.8
    Notes
    [17] - 2 missing data
    [18] - 1 missing data
    [19] - 1 missing data
    Statistical analysis title
    		 Analysis cFGF23-CKD - Day 28
    Comparison groups
    Chronic Kidney Disease v Baseline CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 generalized least squares linear model
    Confidence interval
    Statistical analysis title
    		 Analysis cFGF23-non-CKD - Day 28
    Comparison groups
    Non Chronic Kidney Disease v Baseline non-CKD
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 generalized least squares linear model
    Confidence interval

    Secondary: Phosphate - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 Phosphate - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: mmol / l
        arithmetic mean (standard deviation)
    1.223 ± 0.2526
    1.028 ± 0.1991
    No statistical analyses for this end point

    Secondary: Phosphate - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 Phosphate - Day 0 post-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: mmol / l
        arithmetic mean (standard deviation)
    1.247 ± 0.2582
    1.086 ± 0.2080
    No statistical analyses for this end point

    Secondary: Phosphate - Day 1

    		 Close Top of page
    End point title
    		 Phosphate - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: mmol / l
        arithmetic mean (standard deviation)
    1.118 ± 0.3269
    1.056 ± 0.2063
    No statistical analyses for this end point

    Secondary: Phosphate - Day 7

    		 Close Top of page
    End point title
    		 Phosphate - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [20]
    11
    Units: mmol / l
        arithmetic mean (standard deviation)
    0.9690 ± 0.3981
    0.7609 ± 0.2021
    Notes
    [20] - 2 missing data
    No statistical analyses for this end point

    Secondary: Phosphate - Day 14

    		 Close Top of page
    End point title
    		 Phosphate - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [21]
    10 [22]
    Units: mmol / l
        arithmetic mean (standard deviation)
    1.080 ± 0.4695
    0.693 ± 0.2067
    Notes
    [21] - 2 missing data
    [22] - 1 missing data
    No statistical analyses for this end point

    Secondary: Phosphate - Day 28

    		 Close Top of page
    End point title
    		 Phosphate - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [23]
    10 [24]
    Units: mmol / l
        arithmetic mean (standard deviation)
    1.063 ± 0.2968
    0.884 ± 0.1992
    Notes
    [23] - 2 missing data
    [24] - 1 missing data
    No statistical analyses for this end point

    Secondary: Phosphate excretion - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 Phosphate excretion - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    28.300 ± 14.365
    9.986 ± 5.642
    No statistical analyses for this end point

    Secondary: Phosphate excretion - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 Phosphate excretion - Day 0 post-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    32.26 ± 15.826
    11.57 ± 7.705
    No statistical analyses for this end point

    Secondary: Phosphate excretion - Day 1

    		 Close Top of page
    End point title
    		 Phosphate excretion - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    39.40 ± 17.630
    18.03 ± 9.794
    No statistical analyses for this end point

    Secondary: Phosphate excretion - Day 7

    		 Close Top of page
    End point title
    		 Phosphate excretion - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    28.24 ± 19.00
    23.97 ± 12.27
    No statistical analyses for this end point

    Secondary: Phosphate excretion - Day 14

    		 Close Top of page
    End point title
    		 Phosphate excretion - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    31.67 ± 20.54
    21.25 ± 13.91
    No statistical analyses for this end point

    Secondary: Phosphate excretion - Day 28

    		 Close Top of page
    End point title
    		 Phosphate excretion - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    24.97 ± 17.26
    17.63 ± 11.38
    No statistical analyses for this end point

    Secondary: 1.25 OH Vit D - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 1.25 OH Vit D - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    30.90 ± 13.50
    40.45 ± 11.28
    No statistical analyses for this end point

    Secondary: 1.25 OH Vit D - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 1.25 OH Vit D - Day 0 post-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    29.62 ± 14.63
    40.00 ± 10.64
    No statistical analyses for this end point

    Secondary: 1.25 OH Vit D - Day 1

    		 Close Top of page
    End point title
    		 1.25 OH Vit D - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    26.80 ± 15.938
    28.21 ± 8.363
    No statistical analyses for this end point

    Secondary: 1.25 OH Vit D - Day 7

    		 Close Top of page
    End point title
    		 1.25 OH Vit D - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [25]
    10 [26]
    Units: ng / l
        arithmetic mean (standard deviation)
    16.18 ± 10.760
    13.33 ± 6.989
    Notes
    [25] - 2 missing data
    [26] - 1 missing data
    No statistical analyses for this end point

    Secondary: 1.25 OH Vit D - Day 14

    		 Close Top of page
    End point title
    		 1.25 OH Vit D - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    9 [27]
    10 [28]
    Units: ng / l
        arithmetic mean (standard deviation)
    16.69 ± 10.36
    19.57 ± 12.07
    Notes
    [27] - 3 missing data
    [28] - 1 missing data
    No statistical analyses for this end point

    Secondary: 1.25 OH Vit D - Day 28

    		 Close Top of page
    End point title
    		 1.25 OH Vit D - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [29]
    8 [30]
    Units: ng / l
        arithmetic mean (standard deviation)
    27.94 ± 5.34
    34.2 ± 14.6
    Notes
    [29] - 2 missing data
    [30] - 3 missing data
    No statistical analyses for this end point

    Secondary: NGAL - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 NGAL - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: nmol / ml
        arithmetic mean (standard deviation)
    309295 ± 105612.1
    107982 ± 52683.9
    No statistical analyses for this end point

    Secondary: NGAL - Day 1

    		 Close Top of page
    End point title
    		 NGAL - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: nmol / ml
        arithmetic mean (standard deviation)
    283856 ± 79849.1
    144358 ± 73936.2
    No statistical analyses for this end point

    Secondary: NGAL - Day 7

    		 Close Top of page
    End point title
    		 NGAL - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [31]
    11
    Units: nmol / ml
        arithmetic mean (standard deviation)
    263126 ± 112889.5
    112302 ± 63389.2
    Notes
    [31] - 2 missing data
    No statistical analyses for this end point

    Secondary: NGAL - Day 14

    		 Close Top of page
    End point title
    		 NGAL - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    9 [32]
    10 [33]
    Units: nmol / ml
        arithmetic mean (standard deviation)
    288120 ± 117247
    103499 ± 101550
    Notes
    [32] - 3 missing data
    [33] - 1 missing data
    No statistical analyses for this end point

    Secondary: NGAL - Day 28

    		 Close Top of page
    End point title
    		 NGAL - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [34]
    10 [35]
    Units: nmol / ml
        arithmetic mean (standard deviation)
    284504 ± 13690.3
    104953 ± 79767.5
    Notes
    [34] - 2 missing data
    [35] - 1 missing data
    No statistical analyses for this end point

    Secondary: KIM-1 - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 KIM-1 - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    1347.875 ± 1137.276
    446.379 ± 645.098
    No statistical analyses for this end point

    Secondary: KIM-1 - Day 1

    		 Close Top of page
    End point title
    		 KIM-1 - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    983.667 ± 880.098
    427.091 ± 545.736
    No statistical analyses for this end point

    Secondary: KIM-1 - Day 7

    		 Close Top of page
    End point title
    		 KIM-1 - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [36]
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    1315.567 ± 1419.966
    511.712 ± 614.401
    Notes
    [36] - 2 missing data
    No statistical analyses for this end point

    Secondary: KIM-1 - Day 14

    		 Close Top of page
    End point title
    		 KIM-1 - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    9 [37]
    10 [38]
    Units: pg / ml
        arithmetic mean (standard deviation)
    1692.33 ± 1614.113
    530.75 ± 531.363
    Notes
    [37] - 3 missing data
    [38] - 1 missing data
    No statistical analyses for this end point

    Secondary: KIM-1 - Day 28

    		 Close Top of page
    End point title
    		 KIM-1 - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [39]
    10 [40]
    Units: pg / ml
        arithmetic mean (standard deviation)
    1275.433 ± 1119.956
    320.267 ± 401.454
    Notes
    [39] - 2 missing data
    [40] - 1 missing data
    No statistical analyses for this end point

    Secondary: IL-6 - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 IL-6 - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    15.2033 ± 10.3474
    16.8536 ± 15.3659
    No statistical analyses for this end point

    Secondary: IL-6 - Day 1

    		 Close Top of page
    End point title
    		 IL-6 - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    12.2008 ± 6.97318
    18.1291 ± 17.06064
    No statistical analyses for this end point

    Secondary: IL-6 - Day 7

    		 Close Top of page
    End point title
    		 IL-6 - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [41]
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    12.5020 ± 11.6822
    18.2536 ± 30.2515
    Notes
    [41] - 2 missing data
    No statistical analyses for this end point

    Secondary: IL-6 - Day 14

    		 Close Top of page
    End point title
    		 IL-6 - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [42]
    10 [43]
    Units: ng / l
        arithmetic mean (standard deviation)
    12.922 ± 9.22766
    18.497 ± 37.18214
    Notes
    [42] - 2 missing data
    [43] - 1 missing data
    No statistical analyses for this end point

    Secondary: IL-6 - Day 28

    		 Close Top of page
    End point title
    		 IL-6 - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [44]
    10 [45]
    Units: ng / l
        arithmetic mean (standard deviation)
    10.092 ± 5.35425
    13.441 ± 18.84567
    Notes
    [44] - 2 missing data
    [45] - 1 missing data
    No statistical analyses for this end point

    Secondary: TNF-α - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 TNF-α - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    12.11667 ± 4.17064
    7.84545 ± 2.22412
    No statistical analyses for this end point

    Secondary: TNF-α - Day 1

    		 Close Top of page
    End point title
    		 TNF-α - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    13.28333 ± 4.97756
    9.14545 ± 2.68714
    No statistical analyses for this end point

    Secondary: TNF-α - Day 7

    		 Close Top of page
    End point title
    		 TNF-α - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [46]
    11
    Units: ng / l
        arithmetic mean (standard deviation)
    11.39 ± 2.51239
    7.90 ± 2.41039
    Notes
    [46] - 2 missing data
    No statistical analyses for this end point

    Secondary: TNF-α - Day 14

    		 Close Top of page
    End point title
    		 TNF-α - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [47]
    10 [48]
    Units: ng / l
        arithmetic mean (standard deviation)
    12.37 ± 3.8836
    10.44 ± 12.1930
    Notes
    [47] - 2 missing data
    [48] - 1 missing data
    No statistical analyses for this end point

    Secondary: TNF-α - Day 28

    		 Close Top of page
    End point title
    		 TNF-α - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [49]
    10 [50]
    Units: ng / l
        arithmetic mean (standard deviation)
    12.91 ± 4.68483
    8.61 ± 3.62628
    Notes
    [49] - 2 missing data
    [50] - 1 missing data
    No statistical analyses for this end point

    Secondary: hsCRP - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 hsCRP - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: mg / l
        arithmetic mean (standard deviation)
    9.81 ± 10.67
    10.08 ± 15.67
    No statistical analyses for this end point

    Secondary: hsCRP - Day 1

    		 Close Top of page
    End point title
    		 hsCRP - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: mg / l
        arithmetic mean (standard deviation)
    8.97 ± 10.87
    10.46 ± 16.98
    No statistical analyses for this end point

    Secondary: hsCRP - Day 7

    		 Close Top of page
    End point title
    		 hsCRP - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [51]
    11
    Units: mg / l
        arithmetic mean (standard deviation)
    11.26 ± 21.64
    16.25 ± 39.91
    Notes
    [51] - 2 missing data
    No statistical analyses for this end point

    Secondary: hsCRP - Day 14

    		 Close Top of page
    End point title
    		 hsCRP - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [52]
    10 [53]
    Units: mg / l
        arithmetic mean (standard deviation)
    9.62 ± 15.12
    22.27 ± 63.63
    Notes
    [52] - 2 missing data
    [53] - 1 missing data
    No statistical analyses for this end point

    Secondary: hsCRP - Day 28

    		 Close Top of page
    End point title
    		 hsCRP - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [54]
    10 [55]
    Units: mg / l
        arithmetic mean (standard deviation)
    7.35 ± 7.32
    11.41 ± 28.08
    Notes
    [54] - 2 missing data
    [55] - 1 missing data
    No statistical analyses for this end point

    Secondary: PTH - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 PTH - Day 0 pre-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    215.81 ± 207.38
    76.28 ± 54.43
    No statistical analyses for this end point

    Secondary: PTH - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 PTH - Day 0 post-infusion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    11 [56]
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    216.20 ± 189.82
    83.15 ± 71.55
    Notes
    [56] - 1 missing data
    No statistical analyses for this end point

    Secondary: PTH - Day 1

    		 Close Top of page
    End point title
    		 PTH - Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    198.00 ± 300.89
    58.65 ± 34.33
    No statistical analyses for this end point

    Secondary: PTH - Day 7

    		 Close Top of page
    End point title
    		 PTH - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [57]
    11
    Units: pg / ml
        arithmetic mean (standard deviation)
    208.28 ± 239.19
    81.45 ± 50.68
    Notes
    [57] - 2 missing data
    No statistical analyses for this end point

    Secondary: PTH - Day 14

    		 Close Top of page
    End point title
    		 PTH - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [58]
    10 [59]
    Units: pg / ml
        arithmetic mean (standard deviation)
    234.23 ± 345.6
    73.49 ± 36.6
    Notes
    [58] - 2 missing data
    [59] - 1 missing data
    No statistical analyses for this end point

    Secondary: PTH - Day 28

    		 Close Top of page
    End point title
    		 PTH - Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [60]
    10 [61]
    Units: pg / ml
        arithmetic mean (standard deviation)
    183.65 ± 213.31
    70.29 ± 32.55
    Notes
    [60] - 2 missing data
    [61] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: Ferritin - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 Ferritin - Day 0 pre-infusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    9 [62]
    10 [63]
    Units: µg / l
        arithmetic mean (standard deviation)
    45.1 ± 25.9
    82.9 ± 53.2
    Notes
    [62] - 3 missing data
    [63] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: Ferritin - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 Ferritin - Day 0 post-infusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    9 [64]
    10 [65]
    Units: µg / l
        arithmetic mean (standard deviation)
    45.9 ± 24.9
    74.5 ± 46.8
    Notes
    [64] - 3 missing data
    [65] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: Ferritin - Day 1

    		 Close Top of page
    End point title
    		 Ferritin - Day 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    9 [66]
    10 [67]
    Units: µg / l
        arithmetic mean (standard deviation)
    204.9 ± 127.7
    259.6 ± 55.2
    Notes
    [66] - 3 missing data
    [67] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: Ferritin - Day 7

    		 Close Top of page
    End point title
    		 Ferritin - Day 7
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    8 [68]
    10 [69]
    Units: µg / l
        arithmetic mean (standard deviation)
    804.4 ± 309.9
    1032.0 ± 231.6
    Notes
    [68] - 4 missing data
    [69] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: Ferritin - Day 14

    		 Close Top of page
    End point title
    		 Ferritin - Day 14
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    8 [70]
    8 [71]
    Units: µg / l
        arithmetic mean (standard deviation)
    554.1 ± 320.9
    719.1 ± 271.5
    Notes
    [70] - 4 missing data
    [71] - 3 missing data
    No statistical analyses for this end point

    Other pre-specified: Ferritin - Day 28

    		 Close Top of page
    End point title
    		 Ferritin - Day 28
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    7 [72]
    7 [73]
    Units: µg / l
        arithmetic mean (standard deviation)
    281.9 ± 153.1
    438.9 ± 176.0
    Notes
    [72] - 5 missing data
    [73] - 4 missing data
    No statistical analyses for this end point

    Other pre-specified: TSAT - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 TSAT - Day 0 pre-infusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    13.00 ± 6.047
    18.78 ± 10.421
    No statistical analyses for this end point

    Other pre-specified: TSAT - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 TSAT - Day 0 post-infusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    155.1 ± 56.11
    186.1 ± 41.74
    No statistical analyses for this end point

    Other pre-specified: TSAT - Day 1

    		 Close Top of page
    End point title
    		 TSAT - Day 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: percentage
        arithmetic mean (standard deviation)
    109.3 ± 13.08
    115.8 ± 16.13
    No statistical analyses for this end point

    Other pre-specified: TSAT - Day 7

    		 Close Top of page
    End point title
    		 TSAT - Day 7
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [74]
    11
    Units: percentage
        arithmetic mean (standard deviation)
    31.55 ± 10.08
    31.64 ± 11.63
    Notes
    [74] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: TSAT - Day 14

    		 Close Top of page
    End point title
    		 TSAT - Day 14
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [75]
    10 [76]
    Units: percentage
        arithmetic mean (standard deviation)
    23.72 ± 6.208
    32.08 ± 8.901
    Notes
    [75] - 2 missing data
    [76] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: TSAT - Day 28

    		 Close Top of page
    End point title
    		 TSAT - Day 28
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [77]
    10 [78]
    Units: percentage
        arithmetic mean (standard deviation)
    22.36 ± 3.825
    31.17 ± 10.605
    Notes
    [77] - 2 missing data
    [78] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: GFR - Day 0 pre-infusion

    		 Close Top of page
    End point title
    		 GFR - Day 0 pre-infusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 pre-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ml / min / m²
        arithmetic mean (standard deviation)
    28.18 ± 9.062
    74.76 ± 15.998
    No statistical analyses for this end point

    Other pre-specified: GFR - Day 0 post-infusion

    		 Close Top of page
    End point title
    		 GFR - Day 0 post-infusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 0 post-infusion
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ml / min / m²
        arithmetic mean (standard deviation)
    28.11 ± 7.737
    76.25 ± 17.437
    No statistical analyses for this end point

    Other pre-specified: GFR - Day 1

    		 Close Top of page
    End point title
    		 GFR - Day 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 1
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    12
    11
    Units: ml / min / m²
        arithmetic mean (standard deviation)
    29.93 ± 8.401
    74.41 ± 17.227
    No statistical analyses for this end point

    Other pre-specified: GFR - Day 7

    		 Close Top of page
    End point title
    		 GFR - Day 7
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 7
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [79]
    11
    Units: ml / min / m²
        arithmetic mean (standard deviation)
    29.76 ± 9.912
    77.35 ± 23.388
    Notes
    [79] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: GFR - Day 14

    		 Close Top of page
    End point title
    		 GFR - Day 14
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 14
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [80]
    10 [81]
    Units: ml / min / m²
        arithmetic mean (standard deviation)
    28.24 ± 8.737
    81.50 ± 20.077
    Notes
    [80] - 2 missing data
    [81] - 1 missing data
    No statistical analyses for this end point

    Other pre-specified: GFR - Day 28

    		 Close Top of page
    End point title
    		 GFR - Day 28
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 28
    End point values
    		 Chronic Kidney Disease Non Chronic Kidney Disease
    Number of subjects analysed
    10 [82]
    10 [83]
    Units: ml / min / m²
        arithmetic mean (standard deviation)
    32.29 ± 9.773
    80.60 ± 22.622
    Notes
    [82] - 2 missing data
    [83] - 1 missing data
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    4 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events occurred in this short-term study (study duration of 4 weeks per patient). No new risks were identified and there was no increase in known risks. During the study no safety measures had to be taken for safety reasons.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2017
    additional visit after 24 hours

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32215701
    http://www.ncbi.nlm.nih.gov/pubmed/29747838
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 10:54:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA