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    Clinical Trial Results:
    A prospective randomisd open label study to determine the effects of intravenous iron administration on markers of acute kidney injury in chronic kidney disease (CKD)

    Summary
    EudraCT number
    		 2010-020452-64
    Trial protocol
    		 GB  
    Global end of trial date
    08 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2022
    First version publication date
    08 May 2022
    Other versions
    Summary report(s)
    		 The comparative effect of intravenous iron on oxidative stress and inflammation in patients with Chronic Kidney Disease (CKD) and iron deficiency - A randomized controlled-pilot study. Short title: IR

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    version2.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hull University Teaching Hospitals NHS Trust
    Sponsor organisation address
    Castle Road, Cottingham, United Kingdom, HU16 5JQ
    Public contact
    Research and Development, Hull University Teaching Hospitals NHS Trust, +44 01482 461903, research.development@hey.nhs.uk
    Scientific contact
    Academic Renal Research, Hull University Teaching Hospitals NHS Trust, +44 01482 605260, sunil.bhandari@hey.nhs.uk
    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
    08 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether three preparations of intravenous iron therapy affect markers of kidney injury including NGAL levels in serum and urine as a result of intravenous Iron therapy in patients with chronic kidney disease (CKD). The primary objective of this study is to: •To assess the effects of three preparations of intravenous (IV) iron in a cohort of CKD patients with biochemical functional or absolute iron deficiency (ferritin level less than 200 microg/l or/and transferrin saturation of <20%) on measures renal injury. •To determine whether iron isomaltoside, iron sucrose and iron dextran differ in their effects on markers of renal injury in comparison to baseline measures during the lead in period. •To determine whether IVI iron leads to potential transient AKI from assessment of changes in markers of renal injury from baseline markers prior to iron administration. To determine for iron isomaltoside if there is a difference related to dose of drug (low dose and normal dose)
    Protection of trial subjects
    Robust eligibility criteria to ensure that potential participants who could not successfully complete the required protocol assessments were not entered into the trial. Blood value ranges were specified to ensure only participants who require iron infusions and would contribute to the primary and secondary outcomes of the trial. Women who were pregnant, intending to become pregnant or lactating were excluded from the trial. Certain medical conditions excluded participants so they were unnecessarily enrolled in a trial that would neither benefit them or the outcome of the trial.
    Background therapy
    		 There were no other treatments given that were not test or comparators for the trial.
    Evidence for comparator
    		 • To assess the effects of three preparations of intravenous (IV) iron in a cohort of CKD patients with biochemical functional or absolute iron deficiency (ferritin level less than 200 g/l or/and transferrin saturation of <20%) on measures renal injury. • To determine whether iron sucrose, iron isomaltoside and iron dextran differ in their effects on markers of renal injury in comparison to baseline measures during the lead in period. • To determine whether IVI iron leads to potential transient AKI from assessment of changes in markers of renal injury from baseline markers prior to iron administration. • To determine if changes in the above measurements vary between low dose and normal dose Iron isomaltoside
    Actual start date of recruitment
    25 Apr 2014
    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
    United Kingdom: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    0
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 In this randomized open-label explorative single center study in the U.K, non-dialysis-dependent CKD patients with iron deficiency were randomized (1:1:1:1) to a single infusion of 200 mg Iron Dextran, or Iron Sucrose (IS) or 200 mg or 1000 mg Ferric Derisomaltose (FDI) and were followed up for 3 months.

    Pre-assignment
    Screening details
    		 Patients will be evaluated at baseline and according to the schedule after administration of iron replacement therapy. They will then receive routine clinical care until the end of the study. After one year a clinical check of their medical records will made to identify any hospital admissions, any treatment with dialysis, morbidities and mortalit

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Number of subjects in period 1
    		single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI)
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    10
    Period 2
    Period 2 title
    Baseline (V2a)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Number of subjects in period 2
    		single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    10
    Period 3
    Period 3 title
    2hr Post Iron (V2b)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Number of subjects in period 3
    		single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI)
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    10
    Period 4
    Period 4 title
    1 Day post Iron infusion (V3a)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Number of subjects in period 4
    		single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI)
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    10
    Period 5
    Period 5 title
    1 week post Iron infusion (V3b)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Number of subjects in period 5
    		single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI)
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    9
    Not completed
    0
    0
    0
    1
         Adverse event, serious fatal
    -
    -
    -
    1
    Period 6
    Period 6 title
    1 month post Iron infusion (V4)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Number of subjects in period 6
    		single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI)
    Started
    10
    10
    10
    9
    Completed
    10
    10
    10
    9
    Period 7
    Period 7 title
    3 months post Iron infusion (V5)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 single infusion of 200 mg iron dextran
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Investigational medicinal product name
    Cosmofer 200mg IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 Single infusion of 1000mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 1000mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Arm title
    		 single infusion of 200 mg iron sucrose
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Venofer 200mg IV
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France)

    Arm title
    		 Single infusion of 200mg ferric derisomaltose (FDI)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Monofer 200mg IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were recruited and randomly allocated in a 1:1:1:1 ratio to receive a single infusion of either 200 mg IS (Venofer, Vifor Pharma, Paris, France), 200 mg ID (Cosmofer, Pharmacosmos A/S, Holbaek, Denmark), or 200 mg or 1,000 mg FDI (Monofer, Pharmacosmos A/S) as per summary product characteristics and standard practice in our institution

    Number of subjects in period 7
    		single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI)
    Started
    10
    9
    10
    10
    Completed
    10
    7
    10
    10
    Not completed
    0
    2
    0
    0
         Physician decision
    -
    1
    -
    -
         Pregnancy
    -
    1
    -
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -
    Reporting group title
    single infusion of 200 mg iron dextran
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 1000mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Reporting group title
    single infusion of 200 mg iron sucrose
    Reporting group description
    		 -

    Reporting group title
    Single infusion of 200mg ferric derisomaltose (FDI)
    Reporting group description
    		 -

    Subject analysis set title
    Oxidative Stress and labile plasma iron
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Administration of IV iron resulted in a rise in mean TBARS level within 2 hours (pre-infusion: 1,083.0 ± 117.1 nM, 2 hours post-infusion: 1,552.6 ± 156.0 nM; p = 0.060, all groups combined) (Fig. 2). The increased levels returned to baseline within 1 week. The greatest rise in TBARS was noted in the 1,000 mg FDI group, which was not statistically significant (pre-infusion: 846.0 ± 108.9 nM, 2 hours post-infusion: 1,865.0 ± 203.2 nM; p = 0.250). There was a non-statistically significant increase with IS that occurred 1 week post-infusion (pre-infusion: 906.3 ± 140.9 nM, 1 week post-infusion: 1,261.3 ± 369.3 nM; p = 0.990). There were no statistically significant differences for the effect on TBARS between products used or between the high-dose and low-dose FDI.

    Subject analysis set title
    Labile plasma iron (LBI)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Mean LPI levels increased significantly within 2 hours of infusion and returned to baseline within 1 week (pre-infusion: 1.4 ± 0.5 ΔFU/min, 2 hours post-infusion: 7.4 ± 2.4 ΔFU/min; p = 0.006, all groups combined) (Fig. 3). LPI increased in the ID and IS groups, but these did not reach statistical significance. The concentration of LPI with 200 mg FDI remained constant and similar to the baseline level throughout the study. There was a significant increase in LPI with 1,000 mg FDI (pre-infusion: 0.33 ± 0.2 ΔFU/min, 2 hours post-infusion: 19.6 ± 7.1 ΔFU/min; p < 0.001), and the level at 2 hours post-infusion was significantly higher when compared to the 200 mg FDI group (19.6 ± 7.1 ΔFU/min vs. 1.6 ± 0.8 ΔFU/min; p < 0.001). These changes resolved within 1 week.

    Subject analysis set title
    CRP level (Inflammation)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    There was a rise in mean CRP level within a day of infusion, which returned to baseline levels within 1 month (pre-infusion: 7.5 ± 1.6 mg/L, 1 day post-infusion: 17.6 ± 8.0 mg/L; p = 0.400/ 1 month post-infusion: 7.5 ± 1.7 mg/L; p > 0.999, all groups combined). This rise was more evident in patients receiving IS (pre-infusion: 8.1 ± 3.3 mg/L, 1 day post-infusion: 36.1 ± 27.0 mg/L; p = 0.550). The changes in CRP did not reach statistical significance for FDI at any dose (Fig. 4).

    Subject analysis set title
    Interleukin concentrations
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A transient fall in IL-10 within one month and a rise in IL-8 within 1 week of IV iron infusion were observed across the treatment groups; IL-6 was unaffected. IL-1β did not reach detectable levels during the study. A transient rise in IL-10 within 2 hours of infusion was noted with IS

    Subject analysis set title
    Haemoglobin concentration
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For all groups combined, hemoglobin concentration rose to its maximal level after one month and was sustained until the end of the study at 3 months (p > 0.999). The increase in hemoglobin concentration was not significantly different between the iron compounds, and no statistically significant difference was noted between high-dose and low-dose FDI (p > 0.999 throughout study)

    Subject analysis set title
    TSAT
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    TSAT increased within 2 hours post-infusion (up to 80%, all groups combined) and returned to baseline level by the first week (Fig. 5). This transient rise from baseline to 2 hours post-infusion was statistically significant in both the 1,000 mg FDI (17.8% to 98.7%; p < 0.001) and IS groups (21.1% to 91.4%; p < 0.001). High-dose FDI produced a significant change in TSAT at 2 hours and 1 day post-infusion when compared with low-dose FDI that persisted for 1 week (FDI of 1,000 mg vs. 200 mg; 2 hours post-infusion: 98.7% vs. 58.3%, p = 0.005; 1 day post-infusion: 100% vs. 51.8%, p < 0.001). There was no statistically significant difference between the different iron preparations at 2 hours post-infusion.

    Subject analysis set title
    Serrum ferritin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The mean SF level rose within 2 hours post-infusion to achieve its maximal mean concentration at 1 week (pre-infusion: 68.8 ± 8.0 μg/L, 1 week post-infusion: 216.2 ± 36.6 μg/L, 3 months post-infusion: 122.6 ± 23.1 μg/L; all groups combined) (Fig. 6). The 1,000 mg FDI group produced the greatest and longest-lasting iron repletion (pre-infusion: 69.1 ± 18.4 μg/L, 1 week post-infusion: 505.9 ± 105.5 μg/L, 3 months post-infusion: 271.0 ± 83.3 μg/L), which remained significantly higher than baseline throughout the study (baseline to 1 week post-infusion, p < 0.001; baseline to 3 months post-infusion, p = 0.007). The 1,000 mg FDI dose achieved a statistically significantly greater change in SF when compared to the 200 mg FDI dose throughout the study (p < 0.001).

    Subject analysis set title
    PWV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    There was a trend for a reduction in mean PWV throughout the study across all groups, which did not reach statistical significance (pre-infusion: 7.5 ± 0.4 m/sec, 3 months post-infusion: 6.7 ± 0.4 m/sec; p > 0.999). There was no significant difference between the compound used and improvement in PWV. No difference was noted between high-dose and low-dose FDI. A similar improvement tendency was observed for augmentation index

    Subject analysis set title
    E-selectin and P-selectin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    IV iron did not significantly affect E-selectin during the study, regardless of iron preparation or dose. A non-statistically significant decrease in mean P-selectin level was seen (pre-infusion: 75.0 ± 6.4 ng/mL; 2 hours post-infusion: 72.4 ± 6.5 ng/mL; 3 months post-infusion: 68.7 ± 6.9 ng/mL; p > 0.999, all groups combined); no significant differences in P-selectin were seen between the different IV iron groups or between different doses of FDI

    Subject analysis set title
    SF-36 Quality of Life Questionnaire
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    There was a trend for improvement in all domains of the SF-36 following iron administration for all iron treatment groups combined and with each compound separately through the completion of the study. This was not statistically significant

    Subject analysis set title
    Augementation Index (%)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    An indirect measure of arterial stiffness and increases with age.

    Primary: SF-36 Questionnaire

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    End point title
    		 SF-36 Questionnaire
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 1 month, 3 months
    End point values
    		 single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects analysed
    10
    9
    10
    10
    10
    10
    10
    10
    10
    10
    10
    9
    Units: quantitative units
    arithmetic mean (standard error)
        Physical Status Component
    41.0 ( 2.4 )
    35.3 ( 3.6 )
    36.0 ( 3.6 )
    38.5 ( 4.5 )
    45.0 ( 3.3 )
    38.7 ( 4.2 )
    37.1 ( 4.9 )
    38.6 ( 4.5 )
    42.5 ( 3.7 )
    35.7 ( 3.6 )
    32.9 ( 4.0 )
    40.1 ( 4.2 )
        Mental status component
    43.9 ( 4.1 )
    45.9 ( 4.5 )
    41.6 ( 3.8 )
    40.3 ( 2.7 )
    47.1 ( 3.3 )
    48.7 ( 4.8 )
    45.5 ( 4.7 )
    45.4 ( 4.4 )
    44.1 ( 3.0 )
    41.9 ( 6.2 )
    44.5 ( 6.4 )
    44.3 ( 4.9 )
        Physical functioning
    59.5 ( 8.5 )
    40.6 ( 10.1 )
    47.0 ( 11.0 )
    54.5 ( 11.6 )
    66.7 ( 7.4 )
    43.8 ( 12.6 )
    52.1 ( 16.2 )
    48.9 ( 12.9 )
    59.4 ( 11.0 )
    39.0 ( 15.2 )
    42.5 ( 16.1 )
    52.5 ( 11.1 )
        Role limitations due to physical functioning
    47.5 ( 10.5 )
    43.8 ( 11.4 )
    44.4 ( 13.4 )
    49.4 ( 11.5 )
    65.3 ( 8.4 )
    53.1 ( 12.0 )
    40.2 ( 14.6 )
    52.8 ( 13.3 )
    54.9 ( 10.2 )
    40.0 ( 13.8 )
    32.3 ( 15.8 )
    56.3 ( 11.8 )
        Bodily pain
    62.9 ( 10.1 )
    51.9 ( 9.7 )
    51.8 ( 9.0 )
    54.9 ( 10.7 )
    69.4 ( 8.3 )
    73.0 ( 9.8 )
    61.4 ( 13.2 )
    56.6 ( 9.6 )
    62.8 ( 9.6 )
    53.6 ( 8.6 )
    43.2 ( 11.6 )
    62.3 ( 9.5 )
        General health
    42.7 ( 5.3 )
    34.2 ( 6.4 )
    24.4 ( 6.1 )
    25.8 ( 7.4 )
    49.9 ( 6.0 )
    35.1 ( 9.9 )
    28.0 ( 8.9 )
    37.8 ( 11.0 )
    43.7 ( 7.7 )
    30.4 ( 12.3 )
    25.7 ( 9.0 )
    35.4 ( 11.3 )
        Vitality
    36.9 ( 6.2 )
    40.3 ( 5.5 )
    26.3 ( 8.9 )
    23.8 ( 5.9 )
    46.5 ( 6.6 )
    49.2 ( 8.0 )
    42.9 ( 9.9 )
    34.7 ( 6.6 )
    45.1 ( 7.5 )
    33.8 ( 12.6 )
    36.5 ( 11.0 )
    32.0 ( 8.6 )
        Social function
    60.0 ( 10.0 )
    58.3 ( 11.4 )
    56.3 ( 10.4 )
    58.8 ( 8.8 )
    70.8 ( 8.1 )
    64.1 ( 11.7 )
    60.7 ( 12.9 )
    69.4 ( 11.2 )
    63.9 ( 9.2 )
    55.0 ( 14.0 )
    60.4 ( 16.6 )
    68.8 ( 9.7 )
        Role limitations due to emotional functioning
    60.8 ( 10.5 )
    62.0 ( 11.9 )
    55.0 ( 13.0 )
    51.7 ( 10.3 )
    75.0 ( 8.4 )
    62.5 ( 13.9 )
    60.7 ( 14.5 )
    67.4 ( 11.5 )
    58.3 ( 12.4 )
    43.3 ( 15.2 )
    54.2 ( 16.1 )
    68.7 ( 12.0 )
        Mental health
    70.0 ( 7.5 )
    67.2 ( 10.0 )
    64.5 ( 6.8 )
    58.5 ( 4.2 )
    70.6 ( 6.3 )
    77.5 ( 9.2 )
    69.3 ( 9.3 )
    64.4 ( 7.5 )
    68.9 ( 4.8 )
    68.0 ( 13.9 )
    65.0 ( 12.6 )
    63.1 ( 7.4 )
    Attachments
    		 Untitled (Filename: SF-36.pdf)
    Statistical analysis title
    		 Quality of life
    Statistical analysis description
    There was a trend for improvement in all domains of the SF-36 following iron administration for all iron treatment groups combined and with each compound separately through the completion of the study. This was not statistically significant
    Comparison groups
    single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.999
    Method
    		 Chi-squared
    Parameter type
    		 No parameter estimated.
    Confidence interval

    Primary: P-Selectin

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    End point title
    		 P-Selectin
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 2hr, 1 day, 1 week, 1 month, 3 months
    End point values
    		 single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects analysed
    10
    9
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    9
    Units: ng/ml
        arithmetic mean (standard error)
    92.9 ( 18.5 )
    61.1 ( 6.1 )
    76.4 ( 15.1 )
    69.0 ( 7.6 )
    92.4 ( 18.1 )
    64.1 ( 7.3 )
    77.5 ( 17.1 )
    59.9 ( 8.4 )
    86.4 ( 15.4 )
    83.3 ( 14.2 )
    65.9 ( 16.9 )
    56.9 ( 6.1 )
    83.0 ( 17.2 )
    60.1 ( 8.4 )
    96.2 ( 18.7 )
    70.2 ( 8.5 )
    79.7 ( 9.1 )
    67.2 ( 9.7 )
    62.1 ( 9.1 )
    92.7 ( 34.2 )
    88.0 ( 24.8 )
    68.2 ( 9.7 )
    54.9 ( 4.7 )
    64.2 ( 6.2 )
    Statistical analysis title
    		 Endovascular function
    Statistical analysis description
    IV iron did not significantly affect E-selectin during the study, regardless of iron preparation or dose. A non-statistically significant decrease in mean P-selectin level was seen (pre-infusion: 75.0 ± 6.4 ng/mL; 2 hours post-infusion: 72.4 ± 6.5 ng/mL; 3 months post-infusion: 68.7 ± 6.9 ng/mL; p > 0.999, all groups combined); no significant differences in P-selectin were seen between the different IV iron groups or between different doses of FDI
    Comparison groups
    single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999 [1]
    Method
    		 Chi-squared
    Parameter type
    		 No parameter estimated.
    Confidence interval
    Notes
    [1] - Non-statistically significant.

    Primary: E-selectin

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    End point title
    		 E-selectin
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 2hr, 1 day, 1 week, 1 month, 3 months
    End point values
    		 single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects analysed
    10
    9
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    9
    Units: ng/ml
        arithmetic mean (standard error)
    59.8 ( 10.6 )
    68.3 ( 12.7 )
    67.9 ( 16.5 )
    68.5 ( 9.3 )
    61.1 ( 9.7 )
    72.6 ( 11.8 )
    73.0 ( 15.4 )
    76.9 ( 10.1 )
    61.7 ( 10.2 )
    68.6 ( 9.3 )
    72.1 ( 16.5 )
    79.2 ( 11.2 )
    66.6 ( 12.1 )
    72.8 ( 10.6 )
    86.1 ( 20.0 )
    74.4 ( 10.7 )
    62.7 ( 11.2 )
    72.4 ( 10.8 )
    60.8 ( 15.9 )
    69.0 ( 8.4 )
    60.9 ( 13.2 )
    51.5 ( 6.8 )
    71.3 ( 18.9 )
    81.4 ( 14.2 )
    Attachments
    		 Untitled (Filename: j-krcp-20-120suppl5.pdf)
    Statistical analysis title
    		 Endovascular function
    Comparison groups
    single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v Single infusion of 1000mg ferric derisomaltose (FDI) v single infusion of 200 mg iron dextran v single infusion of 200 mg iron sucrose v Single infusion of 200mg ferric derisomaltose (FDI) v Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.999
    Method
    		 Chi-squared
    Parameter type
    		 No parameter estimated.
    Confidence interval

    Secondary: Pulse wave velocity

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    End point title
    		 Pulse wave velocity
    End point description
    End point type
    Secondary
    End point timeframe
    Across all timepoints on all arms.
    End point values
    		 single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI) PWV
    Number of subjects analysed
    10
    9
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    9
    40
    Units: m/sec
        arithmetic mean (standard error)
    8.3 ( 0.9 )
    6.9 ( 1.0 )
    6.9 ( 0.6 )
    8.1 ( 0.6 )
    7.2 ( 1.2 )
    8.1 ( 0.9 )
    6.8 ( 0.6 )
    6.3 ( 0.8 )
    7.2 ( 1.0 )
    7.4 ( 1.0 )
    6.6 ( 0.8 )
    7.7 ( 0.4 )
    7.1 ( 0.7 )
    7.5 ( 1.2 )
    6.5 ( 0.6 )
    7.7 ( 0.4 )
    6.4 ( 0.7 )
    6.9 ( 1.4 )
    7.1 ( 0.6 )
    7.4 ( 1.0 )
    6.8 ( 1.1 )
    6.5 ( 0.7 )
    6.5 ( 0.7 )
    6.9 ( 0.8 )
    7.1 ( 0.4 )
    Attachments
    		 Untitled (Filename: j-krcp-20-120suppl5.pdf)
    No statistical analyses for this end point

    Secondary: Augmentation Index

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    End point title
    		 Augmentation Index
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 2hrs, 1 day, 1 week, 1 month, 3 months
    End point values
    		 single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI) single infusion of 200 mg iron dextran single infusion of 200 mg iron sucrose Single infusion of 200mg ferric derisomaltose (FDI) Single infusion of 1000mg ferric derisomaltose (FDI)
    Number of subjects analysed
    10
    9
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    10
    9
    Units: %
        arithmetic mean (standard error)
    24.4 ( 4.1 )
    20.2 ( 4.8 )
    19.8 ( 2.3 )
    19.7 ( 3.4 )
    21.6 ( 5.0 )
    23.5 ( 3.8 )
    17.1 ( 3.6 )
    18.4 ( 3.9 )
    14.4 ( 5.6 )
    24.4 ( 4.5 )
    19.1 ( 2.8 )
    16.3 ( 3.0 )
    17.0 ( 4.2 )
    21.3 ( 4.9 )
    17.6 ( 2.7 )
    19.1 ( 3.3 )
    19.1 ( 5.6 )
    16.6 ( 4.5 )
    15.6 ( 2.6 )
    20.4 ( 2.7 )
    16.0 ( 4.5 )
    19.4 ( 3.5 )
    14.4 ( 4.4 )
    24.7 ( 3.3 )
    Attachments
    		 Untitled (Filename: j-krcp-20-120suppl5.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The AE reporting period for this trial begins at visit 1, and ends 30 days after the patients final research study visit.
    Adverse event reporting additional description
    Each trial subject will be questioned about adverse events at each visit. The investigator will record all directly observed AEs and all AEs spontaneously reported by the trial subject. A pre-existing condition (i.e. a disorder present before the AE reporting period started and noted on the pre-treatment medical history/physical examination form/
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Adverse events shown within Subject Disposition at the time it occurs.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2012
    Revision of trial protocol. Study has not commenced but this revision is to include a third treatment option arm. Therefore patients will be randomised to one of four arms. the initial study arms remain but the two additional arms include use of the iron preparation Monofer (iron isomaltoside) which is currently on the hospital formula and in clinical use in the United kingdom and locally in Hull and East Yorkshire Hospitals NHS Trust. The reason for the amendment is the increasing use of Monofer (iron isomaltoside) within the department but data remains lacking in comparison to the two conventional iron preparations and the mechanistic data is lacking in all three preparations. Therefore this revised study which is more comprehensive will in the future allow a more evidenced based approach to optimal treatment with parenteral iron therapy and also may lead to cost savings within the health service
    08 Feb 2018
    Reduction of recruitment numbers from 100 to 40
    16 Nov 2018
    The removal of the 1 year post-infusion check of medical records with no negative consequences to the patients who have already completed the trial.

    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/30947751
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