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An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01574326
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:

Objective: In hyperphosphatemic pediatric participants 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

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Chronic Kidney Disease Drug: Placebo Drug: Sevelamer carbonate Phase 2

Detailed Description:
The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
 Drug: Placebo
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

Drug: Sevelamer carbonate
0.8 g sachets of powder for oral suspension or 800 mg tablets
Other Name: Renvela®
Experimental: FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
 Drug: Placebo
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

Drug: Sevelamer carbonate
0.8 g sachets of powder for oral suspension or 800 mg tablets
Other Name: Renvela®


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline (Week 0) to Week 2 in Serum Phosphorus [ Time Frame: Baseline, Week 2 ]
    Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.

  2. Treatment - Emergent Adverse Events (AEs) [ Time Frame: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP) ]
    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 participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.


Secondary Outcome Measures :
  1. Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus [ Time Frame: Baseline, Week 28/Early Termination ]
    Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.
  • The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.

Exclusion Criteria:

  • The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
  • The participant had a non-renal case of hyperphosphatemia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574326


Locations
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Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01574326    
Other Study ID Numbers: SVCARB07609
2011-002329-23 ( EudraCT Number )
DRI12793 ( Other Identifier: Genzyme Corporation )
First Posted: April 10, 2012    Key Record Dates
Results First Posted: July 25, 2016
Last Update Posted: July 25, 2016
Last Verified: June 2016
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Chronic Kidney Disease
Pediatric
Sevelamer Carbonate
Hyperphosphatemia
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
 Metabolic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action