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 |
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
- 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.
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.
We found this trial at
24
sites
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