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

June 14, 2016 updated by: Genzyme, a Sanofi Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Investigational Site Number 8101
      • Bron, France, 69677
        • Investigational Site Number 8102
      • Paris Cedex 19, France, 75935
        • Investigational Site Number 8103
  • Germany
      • Berlin, Germany, 13353
        • Investigational Site Number 8201
      • Marburg, Germany, 35033
        • Investigational Site Number 8202
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Investigational Site Number 8302
      • Vilnius, Lithuania, 08406
        • Investigational Site Number 8301
  • Poland
      • Gdansk, Poland
        • Investigational Site Number 8402
      • Krakow, Poland, 301-663
        • Investigational Site Number 8401
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 8003
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 8005
    • California
      • Los Angeles, California, United States, 90024
        • Investigational Site Number 8013
      • San Francisco, California, United States, 94143
        • Investigational Site Number 8014
    • Florida
      • Orlando, Florida, United States, 32806
        • Investigational Site Number 8025
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Investigational Site Number 8007
    • Iowa
      • Iowa City, Iowa, United States
        • Investigational Site Number 8019
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigational Site Number 8012
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigational Site Number 8008
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigational Site Number 8020
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Investigational Site Number 8022
      • St Louis, Missouri, United States, 63110
        • Investigational Site Number 8023
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Investigational Site Number 8017
    • New York
      • Buffalo, New York, United States, 14222
        • Investigational Site Number 8018
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Investigational Site Number 8009
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Investigational Site Number 8010
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigational Site Number 8011
    • Texas
      • Dallas, Texas, United States, 75390
        • Investigational Site Number 8026
      • Houston, Texas, United States, 77030
        • Investigational Site Number 8016
      • San Antonio, Texas, United States, 78229
        • Investigational Site Number 8001
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Investigational Site Number 8002
      • Richmond, Virginia, United States, 23298-0034
        • Investigational Site Number 8027
    • Washington
      • Seattle, Washington, United States, 98105
        • Investigational Site Number 8006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Renvela®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 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.
Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 28/Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVCARB07609
  • 2011-002329-23 (EudraCT Number)
  • DRI12793 (Other Identifier: Genzyme Corporation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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