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Clinical Trials/NCT01574326
NCT01574326CompletedPhase 2

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

Genzyme, a Sanofi Company32 sites in 5 countries101 target enrollmentStarted: May 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
101
Locations
32
Primary Endpoint
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate

Placebo Comparator

Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).

Intervention: Placebo (Drug)

FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate

Placebo Comparator

Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).

Intervention: Sevelamer carbonate (Drug)

FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Experimental

Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.

Intervention: Placebo (Drug)

FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Experimental

Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.

Intervention: Sevelamer carbonate (Drug)

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus(Baseline, Week 28/Early Termination)

Investigators

Sponsor
Genzyme, a Sanofi Company
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (32)

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