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    Clinical Trial Results:
    A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients with Chronic Kidney Disease

    Summary
    EudraCT number
    		 2011-002329-23
    Trial protocol
    		 LT   PL  
    Global end of trial date
    16 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2016
    First version publication date
    19 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SVCARB07609
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01574326
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street, Cambridge, United States, 02142
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In hyperphosphatemic pediatric subjects with chronic kidney disease (CKD) to: • Evaluate the safety and tolerability of sevelamer carbonate • Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 2012
    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: 8
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    United States: 89
    Worldwide total number of subjects
    101
    EEA total number of subjects
    12
    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)
    20
    Adolescents (12-17 years)
    73
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 29 centres in 4 countries. A total of 128 subjects were screened between 11 May 2012 and 14 November 2014. Of whom, 101 subjects were randomized and 27 were screen failures.

    Pre-assignment
    Screening details
    		 Subjects were stratified in (1:1) by screening body surface area (≥1.2 vs <1.2 m^2) & qualifying serum phosphorus (≥7.0 vs <7.0 mg/dL), to receive either sevelamer carbonate or placebo during 2-week fixed dose period (FDP). Following FDP, subjects entered 26-week dose titration period (DTP), during which all subjects received sevelamer carbonate.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate
    Arm description
    		 Subjects received placebo for sevelamer carbonate for 2 weeks in FDP and thereafter these subjects received sevelamer carbonate for 26 weeks in DTP. In DTP the dose of sevelamer carbonate could be titrated up/down [titrations were based on screening body surface area (BSA) category].
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo in FDP period only
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP:0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75-<1.2 m^2 as powder for oral suspension (POS) &1.6g TID for BSA ≥1.2 m^2 as POS/tablets depending upon subject’s preference. If a child ate <3 meals/snacks/day, dose was only to be given with meals/snacks, eg, if BSA ≥0.75-<1.2 m^2 & 2 meals/snacks /day that subject took 0.8 g BID with meals. In DTP these subjects received sevelamer carbonate. Starting dose was based on screening BSA & same as prescribed in FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks, to achieve a serum phosphorus level within age appropriate normal values, or up to maximum dose as per Investigator’s opinion, Dose titrations were based on BSA category:0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75-<1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 [smaller titrations were permitted based on Investigator’s judgment, but could not be <0.2 g TID with meals/snacks].

    Arm title
    		 FDP-sevelamer carbonate, DTP-sevelamer carbonate
    Arm description
    		 Subjects received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category for 2 weeks in FDP and thereafter these subjects continued to receive sevelamer carbonate in DTP. In DTP dose could be titrated up/down every 2 weeks for 6 weeks and then every 4 weeks to achieve a serum phosphorus level within the age appropriate normal values or, up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 - <1.2 m^2 and 0.8 g TID for BSA ≥1.2 m^2 [smaller titrations were permitted based on Investigator’s judgment, but could not be < 0.2 g TID with meals/snacks].
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sevelamer carbonate
    Investigational medicinal product code
    GZ419831
    Other name
    Renvela ®
    Pharmaceutical forms
    Powder for oral suspension, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75-<1.2 m^2 as POS & 1.6 g TID for BSA ≥1.2 m^2 either as POS or as tablets depending upon subject’s preference. If a child ate <3 meals/snacks/day, dose was only to be given with meals/snacks. For eg. if BSA was ≥0.75-<1.2 m^2 & 2 meals/snacks/day that subject took 0.8 g BID with meals. In DTP these subjects continued to receive sevelamer carbonate. Starting dose in DTP was based on screening BSA & same as dose prescribed during FDP. Dose could be titrated up/down every 2 weeks for 6 weeks & then every 4 weeks, to achieve a serum phosphorus level within age appropriate normal values, or until, maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75-<1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 [smaller titrations were permitted based on Investigator’s judgment, but could not be <0.2 g TID with meals/snacks].

    Number of subjects in period 1
    		FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate FDP-sevelamer carbonate, DTP-sevelamer carbonate
    Started
    51
    50
    Treated
    51
    49
    Completed
    35
    31
    Not completed
    16
    19
         Physician decision
    5
    3
         Adverse Event
    1
    3
         Other: Mainly kidney transplant
    8
    8
         Randomized but not treated
    -
    1
         Withdrawal by Subject
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate
    Reporting group description
    		 Subjects received placebo for sevelamer carbonate for 2 weeks in FDP and thereafter these subjects received sevelamer carbonate for 26 weeks in DTP. In DTP the dose of sevelamer carbonate could be titrated up/down [titrations were based on screening body surface area (BSA) category].

    Reporting group title
    FDP-sevelamer carbonate, DTP-sevelamer carbonate
    Reporting group description
    		 Subjects received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category for 2 weeks in FDP and thereafter these subjects continued to receive sevelamer carbonate in DTP. In DTP dose could be titrated up/down every 2 weeks for 6 weeks and then every 4 weeks to achieve a serum phosphorus level within the age appropriate normal values or, up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 - <1.2 m^2 and 0.8 g TID for BSA ≥1.2 m^2 [smaller titrations were permitted based on Investigator’s judgment, but could not be < 0.2 g TID with meals/snacks].

    Reporting group values
    		 FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate FDP-sevelamer carbonate, DTP-sevelamer carbonate Total
    Number of subjects
    		 51 50 101
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous is reported here for safety set: N= 51 and N=49 for 'FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate' and 'FDP-sevelamer carbonate, DTP-sevelamer carbonate' arms respectively.
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 3.11 ) 13.9 ( 2.75 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 19 37
        Male
    		 33 31 64

    End points

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    End points reporting groups
    Reporting group title
    FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate
    Reporting group description
    		 Subjects received placebo for sevelamer carbonate for 2 weeks in FDP and thereafter these subjects received sevelamer carbonate for 26 weeks in DTP. In DTP the dose of sevelamer carbonate could be titrated up/down [titrations were based on screening body surface area (BSA) category].

    Reporting group title
    FDP-sevelamer carbonate, DTP-sevelamer carbonate
    Reporting group description
    		 Subjects received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category for 2 weeks in FDP and thereafter these subjects continued to receive sevelamer carbonate in DTP. In DTP dose could be titrated up/down every 2 weeks for 6 weeks and then every 4 weeks to achieve a serum phosphorus level within the age appropriate normal values or, up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 - <1.2 m^2 and 0.8 g TID for BSA ≥1.2 m^2 [smaller titrations were permitted based on Investigator’s judgment, but could not be < 0.2 g TID with meals/snacks].

    Subject analysis set title
    FDP- placebo for sevelamer carbonate; DTP– sevelamer carbonate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter subjects received sevelamer carbonate for 26 weeks in DTP.

    Subject analysis set title
    FDP - sevelamer carbonate, DTP – sevelamer carbonate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter subjects continued to receive sevelamer carbonate for 26 weeks in DTP (based on the screening BSA category).

    Subject analysis set title
    FDP -placebo for sevelamer carbonate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received placebo for sevelamer carbonate for first 2 weeks in FDP.

    Subject analysis set title
    FDP - sevelamer carbonate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.

    Primary: Change from Baseline (Week 0) to Week 2 in Serum Phosphorus

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    End point title
    		 Change from Baseline (Week 0) to Week 2 in Serum Phosphorus
    End point description
    Analysis was performed on full analysis set for the fixed dose period (FAS-FDP) and included all treated subjects with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after the first dose of study drug and on or before Week 2. FAS-FDP subjects were analyzed according to their randomized treatment. A confirmatory analysis was conducted using the per protocol set for the fixed dose period (PPS-FDP).
    End point type
    Primary
    End point timeframe
    Baseline, Week 2
    End point values
    		 FDP -placebo for sevelamer carbonate FDP - sevelamer carbonate
    Number of subjects analysed
    49
    48
    Units: mg/dL
    arithmetic mean (standard deviation)
        At Baseline
    7.2 ( 1.841 )
    7.2 ( 2.09 )
        At Week 2
    7.24 ( 2.029 )
    6.34 ( 1.306 )
        Change from Baseline to Week 2
    0.04 ( 1.478 )
    -0.87 ( 1.649 )
    Statistical analysis title
    		 Sevelamer Carbonate vs Placebo
    Statistical analysis description
    Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.
    Comparison groups
    FDP -placebo for sevelamer carbonate v FDP - sevelamer carbonate
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) mean difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.37

    Primary: Treatment – Emergent Adverse Events (AE)

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    End point title
    		 Treatment – Emergent Adverse Events (AE) [1]
    End point description
    A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs - from the time of signing the informed consent through the end of the study for all subjects. SAEs occurring during the 15 days following study completion or early termination were also to be collected. Analysis was performed on safety set, which included all enrolled subjects who received at least 1 dose of study drug. Subjects were analyzed according to actual received treatment.
    End point type
    Primary
    End point timeframe
    Up to 32 Weeks [up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP]
    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 data reported is qualitative, hence, no statistical analysis is provided.
    End point values
    		 FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate FDP-sevelamer carbonate, DTP-sevelamer carbonate
    Number of subjects analysed
    51
    49
    Units: subjects
        Any AE: FDP
    20
    19
        AE related: FDP
    3
    2
        Any SAE: FDP
    1
    4
        SAE related: FDP
    0
    0
        Any AE Leading to Study Drug Discontinuation: FDP
    1
    1
        Any AE: DTP
    42
    35
        AE related: DTP
    9
    4
        Any SAE: DTP
    14
    17
        SAE related: DTP
    2
    2
        Any AE Leading to Study Drug Discontinuation: DTP
    0
    3
        Death
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus

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    End point title
    		 Change from Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
    End point description
    Analysis was performed on full analysis set for the dose titration period (FAS-DTP) and included all treated subjects with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. FAS-DTP subjects were analysed according to their randomized treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28/Early Termination
    End point values
    		 FDP-placebo for sevelamer carbonate, DTP-sevelamer carbonate FDP-sevelamer carbonate, DTP-sevelamer carbonate
    Number of subjects analysed
    49
    46
    Units: mg/dL
    arithmetic mean (standard deviation)
        At Baseline (Week 0)
    7.05 ( 1.797 )
    7.28 ( 2.103 )
        At Week 28 / Early Termination
    5.92 ( 1.612 )
    6.04 ( 1.878 )
        Change from Baseline to Week 28/Early Termination
    -1.13 ( 2.061 )
    -1.23 ( 2.206 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from signature of informed consent form up to final visit regardless of seriousness or relationship to investigational product. SAEs occurring during 15 days following study completion or early termination were also to be collected.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent adverse events (includes non-serious adverse events and serious adverse events as applicable) that is AE that developed/worsened during the ‘on treatment period’ (from the first dose of study drug up to end of study period). Analysis was performed on safety set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    FDP - Placebo
    Reporting group description
    		 Subjects exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).

    Reporting group title
    FDP - Sevelamer carbonate
    Reporting group description
    		 Subjects exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).

    Reporting group title
    DTP - Sevelamer carbonate
    Reporting group description
    		 Subjects who received placebo and subjects who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in subjects who were on sevelamer carbonate in FDP and 183 days in subjects who were on placebo FDP).

    Serious adverse events
    		 FDP - Placebo FDP - Sevelamer carbonate DTP - Sevelamer carbonate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 49 (8.16%)
    31 / 100 (31.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 49 (4.08%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vena Cava Thrombosis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device Dislocation
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device Malfunction
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device Occlusion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extravasation
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney Transplant Rejection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental Status Changes
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous Fistula Site Complication
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous Fistula Thrombosis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Constipation
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shunt Occlusion
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Focal Segmental Glomerulosclerosis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flank Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter Site Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fungal Peritonitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic Inflammatory Disease
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis Bacterial
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginitis Chlamydial
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella Zoster Virus Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid Overload
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FDP - Placebo FDP - Sevelamer carbonate DTP - Sevelamer carbonate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 51 (11.76%)
    7 / 49 (14.29%)
    57 / 100 (57.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    7 / 100 (7.00%)
         occurrences all number
    0
    1
    10
    Hypotension
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    8 / 100 (8.00%)
         occurrences all number
    1
    0
    12
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    7 / 100 (7.00%)
         occurrences all number
    0
    1
    8
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 49 (4.08%)
    17 / 100 (17.00%)
         occurrences all number
    2
    2
    19
    General disorders and administration site conditions
    Catheter Site Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    6 / 100 (6.00%)
         occurrences all number
    0
    0
    6
    Pyrexia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    16 / 100 (16.00%)
         occurrences all number
    0
    1
    21
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    6 / 100 (6.00%)
         occurrences all number
    0
    0
    6
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    13 / 100 (13.00%)
         occurrences all number
    0
    1
    18
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 49 (0.00%)
    9 / 100 (9.00%)
         occurrences all number
    2
    0
    13
    Diarrhoea
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    8 / 100 (8.00%)
         occurrences all number
    0
    1
    10
    Nausea
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 49 (0.00%)
    15 / 100 (15.00%)
         occurrences all number
    2
    0
    21
    Vomiting
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 49 (0.00%)
    19 / 100 (19.00%)
         occurrences all number
    4
    0
    28
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    7 / 100 (7.00%)
         occurrences all number
    0
    0
    10
    Musculoskeletal and connective tissue disorders
    Pain In Extremity
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    8 / 100 (8.00%)
         occurrences all number
    0
    1
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    6 / 100 (6.00%)
         occurrences all number
    0
    0
    7
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    10 / 100 (10.00%)
         occurrences all number
    0
    0
    10

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2011
    - Added an exclusion criterion to clarify that subjects with non-renal causes of hyperphosphatemia are not eligible. - Added re-screening due to the difficulty in enrolling pediatric subjects. - Clarified that if a child eats less than 3 meals/snacks per day, sevelamer carbonate or placebo should only be given with meals/snacks and not on an empty stomach. - Clarified that subjects who require a dose of less than 0.2 g TID with meals/snacks will be discontinued from treatment and withdrawn from the study. - Clarified that the drug preparation instructions apply to both sevelamer carbonate and placebo. - Clarified the collection and reporting of adverse events. - Clarified that subjects who become pregnant will be withdrawn from the study. - Clarified that stored samples that are not collected will not be a protocol deviation.

    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
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