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

Phase 2

Completed

Conditions: Chronic Kidney Disease
Hyperphosphatemia

Interventions: Drug: Placebo
Drug: Sevelamer carbonate

Registration Number: NCT01574326

Lead Sponsor: Genzyme, a Sanofi Company

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	Placebo	Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	Placebo	Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	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).
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus	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.
Treatment - Emergent Adverse Events (AEs)	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

Name	Time	Method
Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus	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.

Trial Locations

Locations (32): Investigational Site Number 8017
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Livingston, New Jersey, United States
Investigational Site Number 8007
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Atlanta, Georgia, United States
Investigational Site Number 8009
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Greenville, North Carolina, United States
Investigational Site Number 8003
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Birmingham, Alabama, United States
Investigational Site Number 8008
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Boston, Massachusetts, United States
Investigational Site Number 8016
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Houston, Texas, United States
Investigational Site Number 8001
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San Antonio, Texas, United States
Investigational Site Number 8006
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Seattle, Washington, United States
Investigational Site Number 8020
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Detroit, Michigan, United States
Investigational Site Number 8005
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Birmingham, Alabama, United States
Investigational Site Number 8013
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Los Angeles, California, United States
Investigational Site Number 8014
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San Francisco, California, United States
Investigational Site Number 8025
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Orlando, Florida, United States
Investigational Site Number 8019
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Iowa City, Iowa, United States
Investigational Site Number 8012
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Baltimore, Maryland, United States
Investigational Site Number 8022
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Kansas City, Missouri, United States
Investigational Site Number 8018
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Buffalo, New York, United States
Investigational Site Number 8023
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St Louis, Missouri, United States
Investigational Site Number 8010
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Portland, Oregon, United States
Investigational Site Number 8011
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Philadelphia, Pennsylvania, United States
Investigational Site Number 8026
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Dallas, Texas, United States
Investigational Site Number 8002
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Charlottesville, Virginia, United States
Investigational Site Number 8027
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Richmond, Virginia, United States
Investigational Site Number 8101
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Bordeaux, France
Investigational Site Number 8102
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Bron, France
Investigational Site Number 8103
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Paris Cedex 19, France
Investigational Site Number 8202
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Marburg, Germany
Investigational Site Number 8201
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Berlin, Germany
Investigational Site Number 8302
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Kaunas, Lithuania
Investigational Site Number 8301
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Vilnius, Lithuania
Investigational Site Number 8402
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Gdansk, Poland
Investigational Site Number 8401
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Krakow, Poland