Trials / Completed
CompletedNCT01503736
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Panion & BF Biotech Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ferric citrate | 0g/day ferric citrate capsule, TID for 56 days |
| DRUG | ferric citrate | 4g/day ferric citrate capsule, TID for 56 days |
| DRUG | ferric citrate | 6 g/day ferric citrate capsule, TID for 56 days |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2012-06-01
- First posted
- 2012-01-04
- Last updated
- 2020-01-13
Locations
5 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01503736. Inclusion in this directory is not an endorsement.