At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 101 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 0.8 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo and Sevelamer carbonate for Hyperphosphatemia and Chronic Kidney Disease. Completed, enrolled 101 participants across 32 sites in 5 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia, Chronic Kidney Disease
CountriesFrance, Germany, Lithuania, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartMay 2012
Primary CompletionJun 2015
TodayJul 2026
First PostedApr 10, 2012
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.2 years ago
Interventions
Placebodrug
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
Sevelamer carbonatedrug
0.8 g sachets of powder for oral suspension or 800 mg tablets