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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any - 18
Updated:2/7/2015
Start Date:May 2012
End Date:November 2015
Contact:For site information, send an email with site number to
Email:Contact-Us@sanofi.com

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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

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

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.

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.
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24
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