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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperphosphatemia, Chronic Kidney Disease

In brief

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

Key facts

Study ID

NCT01574326

Run by

Genzyme, a Sanofi Company

People needed

101

Starts

2012-05-01

Expected to finish

2015-06-01

Last updated by the study team

2016-07-25

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Investigational Site Number 8003 — Birmingham, Alabama, United States
• Investigational Site Number 8005 — Birmingham, Alabama, United States
• Investigational Site Number 8013 — Los Angeles, California, United States
• Investigational Site Number 8014 — San Francisco, California, United States
• Investigational Site Number 8025 — Orlando, Florida, United States
• Investigational Site Number 8007 — Atlanta, Georgia, United States
• Investigational Site Number 8019 — Iowa City, Iowa, United States
• Investigational Site Number 8012 — Baltimore, Maryland, United States
• Investigational Site Number 8008 — Boston, Massachusetts, United States
• Investigational Site Number 8020 — Detroit, Michigan, United States
• Investigational Site Number 8022 — Kansas City, Missouri, United States
• Investigational Site Number 8023 — St Louis, Missouri, United States
• Investigational Site Number 8017 — Livingston, New Jersey, United States
• Investigational Site Number 8018 — Buffalo, New York, United States
• Investigational Site Number 8009 — Greenville, North Carolina, United States
• Investigational Site Number 8010 — Portland, Oregon, United States
• Investigational Site Number 8011 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 8026 — Dallas, Texas, United States
• Investigational Site Number 8016 — Houston, Texas, United States
• Investigational Site Number 8001 — San Antonio, Texas, United States
• Investigational Site Number 8002 — Charlottesville, Virginia, United States
• Investigational Site Number 8027 — Richmond, Virginia, United States
• Investigational Site Number 8006 — Seattle, Washington, United States
• Investigational Site Number 8101 — Bordeaux, France
• Investigational Site Number 8102 — Bron, France

Full record on ClinicalTrials.gov

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