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

NCT ID: NCT01574326

Last Updated: 2016-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hyperphosphatemia Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

Sevelamer carbonate

Intervention Type DRUG

0.8 g sachets of powder for oral suspension or 800 mg tablets

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

Sevelamer carbonate

Intervention Type DRUG

0.8 g sachets of powder for oral suspension or 800 mg tablets

Interventions

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Placebo

Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

Intervention Type DRUG

Sevelamer carbonate

0.8 g sachets of powder for oral suspension or 800 mg tablets

Intervention Type DRUG

Other Intervention Names

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Renvela®

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Investigational Site Number 8003

Birmingham, Alabama, United States

Site Status

Investigational Site Number 8005

Birmingham, Alabama, United States

Site Status

Investigational Site Number 8013

Los Angeles, California, United States

Site Status

Investigational Site Number 8014

San Francisco, California, United States

Site Status

Investigational Site Number 8025

Orlando, Florida, United States

Site Status

Investigational Site Number 8007

Atlanta, Georgia, United States

Site Status

Investigational Site Number 8019

Iowa City, Iowa, United States

Site Status

Investigational Site Number 8012

Baltimore, Maryland, United States

Site Status

Investigational Site Number 8008

Boston, Massachusetts, United States

Site Status

Investigational Site Number 8020

Detroit, Michigan, United States

Site Status

Investigational Site Number 8022

Kansas City, Missouri, United States

Site Status

Investigational Site Number 8023

St Louis, Missouri, United States

Site Status

Investigational Site Number 8017

Livingston, New Jersey, United States

Site Status

Investigational Site Number 8018

Buffalo, New York, United States

Site Status

Investigational Site Number 8009

Greenville, North Carolina, United States

Site Status

Investigational Site Number 8010

Portland, Oregon, United States

Site Status

Investigational Site Number 8011

Philadelphia, Pennsylvania, United States

Site Status

Investigational Site Number 8026

Dallas, Texas, United States

Site Status

Investigational Site Number 8016

Houston, Texas, United States

Site Status

Investigational Site Number 8001

San Antonio, Texas, United States

Site Status

Investigational Site Number 8002

Charlottesville, Virginia, United States

Site Status

Investigational Site Number 8027

Richmond, Virginia, United States

Site Status

Investigational Site Number 8006

Seattle, Washington, United States

Site Status

Investigational Site Number 8101

Bordeaux, , France

Site Status

Investigational Site Number 8102

Bron, , France

Site Status

Investigational Site Number 8103

Paris, , France

Site Status

Investigational Site Number 8201

Berlin, , Germany

Site Status

Investigational Site Number 8202

Marburg, , Germany

Site Status

Investigational Site Number 8302

Kaunas, , Lithuania

Site Status

Investigational Site Number 8301

Vilnius, , Lithuania

Site Status

Investigational Site Number 8402

Gdansk, , Poland

Site Status

Investigational Site Number 8401

Krakow, , Poland

Site Status

Countries

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United States France Germany Lithuania Poland

Other Identifiers

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2011-002329-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRI12793

Identifier Type: OTHER

Identifier Source: secondary_id

SVCARB07609

Identifier Type: -

Identifier Source: org_study_id

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