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    Clinical Trial Results:
    An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia

    Summary
    EudraCT number
    		 2015-004155-43
    Trial protocol
    		 LT   DE   PL   FR  
    Global end of trial date
    21 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2019
    First version publication date
    21 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PA-CL-PED-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02688764
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vifor Fresenius Medical Care Renal Pharma France
    Sponsor organisation address
    100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, Paris La Défense Cedex, France, 92042
    Public contact
    Medical Information, Vifor (International) Inc, medinfo@viforpharma.com
    Scientific contact
    Medical Information, Vifor (International) Inc, medinfo@viforpharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001061-PIP01-10
    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
    10 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of PA21 (Velphoro®) in reducing serum phosphorus levels in paediatric and adolescent subjects with CKD (Chronic Kidney Disease) at the end of Stage 1.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki including amendments in force up to and including the time the study was conducted. The study was conducted in compliance with the International Council for Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP), Committee for Proprietary Medicinal Products Guideline (CPMP/ICH/135/95), compliant with the European Union Clinical Trial Directive (Directive 2001/20/EC) and/or the Code of Federal Regulations (CFR) for informed consent and protection of patient rights (21 CFR, Parts 50 and 56), and in accordance with US Food and Drug Administration (FDA) regulations. Study subjects had phosphorus and calcium levels monitored at frequent intervals (weekly during the washout stage of the study). The dose was adjusted at regular intervals to optimise serum phosphorus levels. Stopping rules were in place to ensure withdrawal of subjects whose phosphorus or calcium levels were not controlled within required limits. In addition, the study had an external Data and Safety Monitoring Board (DSMB).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    United States: 53
    Country: Number of subjects enrolled
    Russian Federation: 2
    Worldwide total number of subjects
    85
    EEA total number of subjects
    30
    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)
    29
    Adolescents (12-17 years)
    55
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No study related assessments were performed until signed/dated informed consent had been provided for the subject. The study consisted of a screening period of up to 4 weeks and a washout period of up to 3 weeks for subjects previously taking phosphate binders before randomisation. A total of 120 subjects were screened, of whom 85 were randomized.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PA21 (Velphoro®)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PA21 (Velphoro®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Dose modifications were to follow the same guidelines used in Stage 1.

    Arm title
    		 Calcium Acetate (Phoslyra®)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Calcium Acetate (Phoslyra®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL equivalent to 169 mg (8.45 mEq) calcium. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Dose modifications were to follow the same guidelines used in Stage 1.

    Number of subjects in period 1
    		PA21 (Velphoro®) Calcium Acetate (Phoslyra®)
    Started
    66
    19
    Treated in Stage 1
    66
    19
    Treated in Stage 2
    43
    8
    Completed
    26
    2
    Not completed
    40
    17
         Non-compliance/Physician decision/Withd. subject
    1
    1
         Withdrawal by parent
    3
    -
         AE/Physician decision
    1
    -
         AE/Withdrawal by subject
    1
    -
         AE/Non-compliance with study drug
    1
    -
         Non-compliance/Withdrawal by subject
    -
    2
         AE/Withdrawal by parent/Withdrawal by subject
    1
    1
         Adverse event
    3
    3
         AE/Non-compliance with study drug/Withd. parent
    -
    1
         Lack of efficacy/Physician decision
    -
    1
         AE/Kidney transplant
    1
    -
         Non-compliance with study drug/Physician decision
    2
    -
         Other
    4
    1
         Non-compliance with study drug
    4
    -
         AE/Other
    -
    1
         AE/Withdrawal by parent
    3
    -
         AE/Lack of efficacy
    1
    -
         Other/Withdrawal by parent
    1
    -
         Kidney transplant
    10
    4
         Lack of efficacy
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PA21 (Velphoro®)
    Reporting group description
    		 -

    Reporting group title
    Calcium Acetate (Phoslyra®)
    Reporting group description
    		 -

    Reporting group values
    		 PA21 (Velphoro®) Calcium Acetate (Phoslyra®) Total
    Number of subjects
    		 66 19 85
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 23 6 29
        Adolescents (12-17 years)
    		 42 13 55
        Adults (18-64 years)
    		 1 0 1
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.2 ± 4.07 12.6 ± 3.73 -
    Gender categorical
    Units: Subjects
        Female
    		 34 13 47
        Male
    		 32 6 38
    Subject analysis sets

    Subject analysis set title
    PA21 (Velphoro®) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) Population: all subjects randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.

    Subject analysis set title
    Calcium Acetate (Phoslyra®) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) Population: all subjects randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.

    Subject analysis sets values
    		 PA21 (Velphoro®) - FAS Calcium Acetate (Phoslyra®) - FAS
    Number of subjects
    65
    15
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    23
    5
        Adolescents (12-17 years)
    41
    10
        Adults (18-64 years)
    1
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.1 ± 4.10
    12.3 ± 3.96
    Gender categorical
    Units: Subjects
        Female
    34
    10
        Male
    31
    5

    End points

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    End points reporting groups
    Reporting group title
    PA21 (Velphoro®)
    Reporting group description
    		 -

    Reporting group title
    Calcium Acetate (Phoslyra®)
    Reporting group description
    		 -

    Subject analysis set title
    PA21 (Velphoro®) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) Population: all subjects randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.

    Subject analysis set title
    Calcium Acetate (Phoslyra®) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) Population: all subjects randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.

    Primary: Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group

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    End point title
    		 Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint is defined in just one arm of the study, therefore no statistical analysis can be included on this section.
    End point values
    		 PA21 (Velphoro®) - FAS
    Number of subjects analysed
    65
    Units: mmol/L
        least squares mean (standard error)
    -0.120 ± 0.081
    No statistical analyses for this end point

    Secondary: Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group

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    End point title
    		 Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)
    End point values
    		 Calcium Acetate (Phoslyra®) - FAS
    Number of subjects analysed
    15
    Units: mmol/L
        least squares mean (standard error)
    -0.615 ± 0.320
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Serum Phosphorus Level Within the Age Related Normal Range in Each Stage

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    End point title
    		 Percentage of Participants With Serum Phosphorus Level Within the Age Related Normal Range in Each Stage
    End point description
    Participants With Serum Phosphorus Level Within the Age Related Normal Range in Each Stage
    End point type
    Secondary
    End point timeframe
    Baseline, end of stage 1 (up to 10 weeks after treatment start date) and end of stage 2 (up to 34 weeks after treatment start date)
    End point values
    		 PA21 (Velphoro®) - FAS Calcium Acetate (Phoslyra®) - FAS
    Number of subjects analysed
    Units: Participants
        Baseline - Below normal range
    1
    1
        Baseline - Within normal range
    24
    5
        Baseline - Above normal range
    40
    9
        End of Stage 1 - Below normal range
    1
    1
        End of Stage 1 - Within normal range
    39
    6
        End of Stage 1 - Above normal range
    24
    8
        End of Stage 2 - Below normal range
    1
    0
        End of Stage 2 - Within normal range
    23
    2
        End of Stage 2 - Above normal range
    16
    6
    No statistical analyses for this end point

    Post-hoc: Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group

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    End point title
    		 Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group
    End point description
    No subjects were 0 - <2 years old at randomisation.
    End point type
    Post-hoc
    End point timeframe
    From Baseline to End of Stage 1 (up to 10 weeks after treatment start date)
    End point values
    		 PA21 (Velphoro®) - FAS
    Number of subjects analysed
    65
    Units: mmol/L
    least squares mean (standard error)
        >=2 years to <6 years
    -0.078 ± 0.123
        >=6 years to <12 years
    -0.200 ± 0.158
        >=12 years to <=18 years
    -0.149 ± 0.062
    No statistical analyses for this end point

    Post-hoc: Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline

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    End point title
    		 Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline
    End point description
    The levels of Serum Phosphorus (SP) considered at baseline are those above vs within/below Age Related Normal Range
    End point type
    Post-hoc
    End point timeframe
    From Baseline to End of Stage 1 (up to 10 weeks after treatment start date)
    End point values
    		 PA21 (Velphoro®) - FAS
    Number of subjects analysed
    65
    Units: mmol/L
    least squares mean (standard error)
        SP above Age Related Normal Range
    -0.282 ± 0.096
        SP below/within Related Normal Range
    0.082 ± 0.146
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through study completion, up to 34 weeks after treatment start date
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    PA21 (Velphoro®)
    Reporting group description
    		 -

    Reporting group title
    Calcium Acetate (Phoslyra®)
    Reporting group description
    		 -

    Serious adverse events
    		 PA21 (Velphoro®) Calcium Acetate (Phoslyra®)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 66 (27.27%)
    3 / 19 (15.79%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 66 (7.58%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Catheter site haematoma
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture site reaction
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device extrusion
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight increased
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site haematoma
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Benign intracranial hypertension
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related sepsis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PA21 (Velphoro®) Calcium Acetate (Phoslyra®)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 66 (68.18%)
    14 / 19 (73.68%)
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Blood phosphorus increased
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    Dizziness
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 66 (18.18%)
    0 / 19 (0.00%)
         occurrences all number
    14
    0
    Nausea
         subjects affected / exposed
    8 / 66 (12.12%)
    2 / 19 (10.53%)
         occurrences all number
    10
    2
    Vomiting
         subjects affected / exposed
    6 / 66 (9.09%)
    2 / 19 (10.53%)
         occurrences all number
    6
    3
    Constipation
         subjects affected / exposed
    4 / 66 (6.06%)
    1 / 19 (5.26%)
         occurrences all number
    4
    1
    Abdominal pain
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 66 (1.52%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Sinus congestion
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Excessive granulation tissue
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Haematuria
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 19 (10.53%)
         occurrences all number
    5
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 19 (5.26%)
         occurrences all number
    2
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    3 / 66 (4.55%)
    3 / 19 (15.79%)
         occurrences all number
    3
    3
    Hyperkalaemia
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Iron deficiency
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    4 / 66 (6.06%)
    4 / 19 (21.05%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The study was prematurely ended as a result of the modification of study requirements, as agreed with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
    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.

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