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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574326
• Other study ID #: SVCARB07609
• Secondary ID: 2011-002329-23DR
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2012
• Last updated: June 19, 2015
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Objective: In hyperphosphatemic pediatric patients 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

Description:

The study is 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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• The patient has chronic kidney disease (CKD) requiring dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 based on central laboratory results.

• The patient has a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.

Exclusion Criteria:

• The patient has active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major GI tract surgery.

• The patient has a non-renal case of hyperphosphatemia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• sevelamer carbonate
0.8 g sachets of powder for oral suspension or 800 mg tablets
• Placebo
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  France,  Germany,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Visit 3 in serum phosphorus		Baseline and Up to 6 weeks	No
Primary	Number of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)		32 Weeks	Yes
Secondary	Change from Baseline to Visit 11/ET in serum phosphorus		Baseline and 32 Weeks	No