At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 168 enrolled
Drug / intervention
ferric citratedrug
Likely dose
ferric citrate 5.5 mgfrom 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 Long-Term Safety Extension 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 for End Stage Renal Disease and 4 related conditions. Completed, enrolled 168 participants across 34 sites in 2 countries.
Detailed Summary
A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartAug 2012
Primary CompletionJun 2014
Study CompletionAug 2014
TodayJul 2026
First PostedMar 15, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.3 years ago
Interventions
ferric citratedrug
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.