Clinical trial NCT01574326: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Pediatric
Sevelamer Carbonate
Hyperphosphatemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 101
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
timeFrame: Baseline, Week 2
measure: Treatment - Emergent Adverse Events (AEs)
timeFrame: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
Secondary outcomes:
measure: Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
timeFrame: Baseline, Week 28/Early Termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 8003
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site Number 8005
state: Alabama
city: Los Angeles
country: United States
facility: Investigational Site Number 8013
state: California
city: San Francisco
country: United States
facility: Investigational Site Number 8014
state: California
city: Orlando
country: United States
facility: Investigational Site Number 8025
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 8007
state: Georgia
city: Iowa City
country: United States
facility: Investigational Site Number 8019
state: Iowa
city: Baltimore
country: United States
facility: Investigational Site Number 8012
state: Maryland
city: Boston
country: United States
facility: Investigational Site Number 8008
state: Massachusetts
city: Detroit
country: United States
facility: Investigational Site Number 8020
state: Michigan
city: Kansas City
country: United States
facility: Investigational Site Number 8022
state: Missouri
city: St Louis
country: United States
facility: Investigational Site Number 8023
state: Missouri
city: Livingston
country: United States
facility: Investigational Site Number 8017
state: New Jersey
city: Buffalo
country: United States
facility: Investigational Site Number 8018
state: New York
city: Greenville
country: United States
facility: Investigational Site Number 8009
state: North Carolina
city: Portland
country: United States
facility: Investigational Site Number 8010
state: Oregon
city: Philadelphia
country: United States
facility: Investigational Site Number 8011
state: Pennsylvania
city: Dallas
country: United States
facility: Investigational Site Number 8026
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 8016
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8001
state: Texas
city: Charlottesville
country: United States
facility: Investigational Site Number 8002
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 8027
state: Virginia
city: Seattle
country: United States
facility: Investigational Site Number 8006
state: Washington
city: Bordeaux
country: France
facility: Investigational Site Number 8101
city: Bron
country: France
facility: Investigational Site Number 8102
city: Paris Cedex 19
country: France
facility: Investigational Site Number 8103
city: Berlin
country: Germany
facility: Investigational Site Number 8201
city: Marburg
country: Germany
facility: Investigational Site Number 8202
city: Kaunas
country: Lithuania
facility: Investigational Site Number 8302
city: Vilnius
country: Lithuania
facility: Investigational Site Number 8301
city: Gdansk
country: Poland
facility: Investigational Site Number 8402
city: Krakow
country: Poland
facility: Investigational Site Number 8401
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: