At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 441 enrolled
Drug / intervention
ferric citrate, ca acetate, sevelamer carbonate, placebodrug
Likely dose
Not stated in 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 Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
In Brief
A Phase 3 clinical trial evaluating ferric citrate, ca acetate, sevelamer carbonate, placebo for Hyperphosphatemia and Kidney Failure. Completed, enrolled 441 participants across 56 sites in 3 countries.
Detailed Summary
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia, Kidney Failure
CountriesIsrael, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartOct 2010
Primary CompletionJan 2013
Study CompletionFeb 2013
TodayJul 2026
First PostedAug 30, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2013
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago
Interventions
ferric citrate, ca acetate, sevelamer carbonate, placebodrug
All intervention doses will be based on serum phosphorus levels and/or drug label requirements