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

Primary Purpose

Hyperphosphatemia, Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Sevelamer carbonate
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Chronic Kidney Disease, Pediatric, Sevelamer Carbonate, Hyperphosphatemia

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 8003
  • Investigational Site Number 8005
  • Investigational Site Number 8013
  • Investigational Site Number 8014
  • Investigational Site Number 8025
  • Investigational Site Number 8007
  • Investigational Site Number 8019
  • Investigational Site Number 8012
  • Investigational Site Number 8008
  • Investigational Site Number 8020
  • Investigational Site Number 8022
  • Investigational Site Number 8023
  • Investigational Site Number 8017
  • Investigational Site Number 8018
  • Investigational Site Number 8009
  • Investigational Site Number 8010
  • Investigational Site Number 8011
  • Investigational Site Number 8026
  • Investigational Site Number 8016
  • Investigational Site Number 8001
  • Investigational Site Number 8002
  • Investigational Site Number 8027
  • Investigational Site Number 8006
  • Investigational Site Number 8101
  • Investigational Site Number 8102
  • Investigational Site Number 8103
  • Investigational Site Number 8201
  • Investigational Site Number 8202
  • Investigational Site Number 8302
  • Investigational Site Number 8301
  • Investigational Site Number 8402
  • Investigational Site Number 8401

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate

FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
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)
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

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

Full Information

First Posted
April 6, 2012
Last Updated
June 14, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01574326
Brief Title
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Pediatric, Sevelamer Carbonate, Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Arm Type
Placebo Comparator
Arm Description
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
Arm Title
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Renvela®
Intervention Description
0.8 g sachets of powder for oral suspension or 800 mg tablets
Primary Outcome Measure Information:
Title
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Description
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.
Time Frame
Baseline, Week 2
Title
Treatment - Emergent Adverse Events (AEs)
Description
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.
Time Frame
Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
Secondary Outcome Measure Information:
Title
Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
Description
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.
Time Frame
Baseline, Week 28/Early Termination

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8003
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigational Site Number 8005
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigational Site Number 8013
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Investigational Site Number 8014
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Investigational Site Number 8025
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 8007
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Site Number 8019
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Investigational Site Number 8012
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Investigational Site Number 8008
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigational Site Number 8020
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Investigational Site Number 8022
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Investigational Site Number 8023
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number 8017
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Investigational Site Number 8018
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Investigational Site Number 8009
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigational Site Number 8010
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Investigational Site Number 8011
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Site Number 8026
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Investigational Site Number 8016
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 8001
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 8002
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Investigational Site Number 8027
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0034
Country
United States
Facility Name
Investigational Site Number 8006
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Investigational Site Number 8101
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Investigational Site Number 8102
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Investigational Site Number 8103
City
Paris Cedex 19
ZIP/Postal Code
75935
Country
France
Facility Name
Investigational Site Number 8201
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigational Site Number 8202
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Investigational Site Number 8302
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Investigational Site Number 8301
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Investigational Site Number 8402
City
Gdansk
Country
Poland
Facility Name
Investigational Site Number 8401
City
Krakow
ZIP/Postal Code
301-663
Country
Poland

12. IPD Sharing Statement

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

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