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

NCT01574326 | Completed Phase 2 Results DMC

• 3 other identifiers: SVCARB076092011-002329-23DRI12793
• Study Type: interventional
• Target: 101
• Locations: 5 countries
• Sites: 32

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

Conditions

Hyperphosphatemia; Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Pediatric; Sevelamer Carbonate; Hyperphosphatemia

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 2

• 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.

  Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

Secondary Outcomes (1)

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

  Baseline, Week 28/Early Termination

Study Arms (2)

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).

Drug: Placebo; Drug: Sevelamer carbonate

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.

Drug: Placebo; Drug: Sevelamer carbonate

Interventions

Placebo DRUG

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

FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate; FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Sevelamer carbonate DRUG

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

Also known as: Renvela®

FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate; FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (32)

Investigational Site Number 8003

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 8005

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 8013

Los Angeles, California, 90024, United States

Location

Investigational Site Number 8014

San Francisco, California, 94143, United States

Location

Investigational Site Number 8025

Orlando, Florida, 32806, United States

Location

Investigational Site Number 8007

Atlanta, Georgia, 30322, United States

Location

Investigational Site Number 8019

Iowa City, Iowa, United States

Location

Investigational Site Number 8012

Baltimore, Maryland, 21287, United States

Location

Investigational Site Number 8008

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 8020

Detroit, Michigan, 48201, United States

Location

Investigational Site Number 8022

Kansas City, Missouri, 64108, United States

Location

Investigational Site Number 8023

St Louis, Missouri, 63110, United States

Location

Investigational Site Number 8017

Livingston, New Jersey, 07039, United States

Location

Investigational Site Number 8018

Buffalo, New York, 14222, United States

Location

Investigational Site Number 8009

Greenville, North Carolina, 27834, United States

Location

Investigational Site Number 8010

Portland, Oregon, 97201-3098, United States

Location

Investigational Site Number 8011

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 8026

Dallas, Texas, 75390, United States

Location

Investigational Site Number 8016

Houston, Texas, 77030, United States

Location

Investigational Site Number 8001

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 8002

Charlottesville, Virginia, 22908, United States

Location

Investigational Site Number 8027

Richmond, Virginia, 23298-0034, United States

Location

Investigational Site Number 8006

Seattle, Washington, 98105, United States

Location

Investigational Site Number 8101

Bordeaux, 33076, France

Location

Investigational Site Number 8102

Bron, 69677, France

Location

Investigational Site Number 8103

Paris, 75935, France

Location

Investigational Site Number 8201

Berlin, 13353, Germany

Location

Investigational Site Number 8202

Marburg, 35033, Germany

Location

Investigational Site Number 8302

Kaunas, 50009, Lithuania

Location

Investigational Site Number 8301

Vilnius, 08406, Lithuania

Location

Investigational Site Number 8402

Gdansk, Poland

Location

Investigational Site Number 8401

Krakow, 301-663, Poland

Location

MeSH Terms

Conditions

Hyperphosphatemia; Renal Insufficiency, Chronic

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Genzyme Corporation

Contact-US@sanofi.com

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Locations

FR (3); US (23); DE (2); LI (2); PL (2)