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NCT01191255 · ClinicalTrials.gov registry record · Phase 3
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
A Phase 3 study of Kidney Failure and Hyperphosphatemia, sponsored by Keryx Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 441
- Enrollment target
- 20
- Study locations
NCT01191255: Completed Phase 3 study of Kidney Failure and Hyperphosphatemia, sponsored by Keryx Biopharmaceuticals.
NCT01191255 is a Phase 3 study of Kidney Failure and Hyperphosphatemia that has completed, run by Keryx Biopharmaceuticals. The registered enrollment target is 441 participants, below the 563-participant average among 18 other Kidney Failure trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01191255, a Phase 3 study of Kidney Failure and Hyperphosphatemia, has completed, sponsored by Keryx Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 441 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.
Conditions Studied
Interventions
- DRUG ferric citrate, ca acetate, sevelamer carbonate, placebo
Study Locations (20)
Florida
- PAB Clinical Research - Brandon
- Mayo Clinic - Jacksonville
- ASA Clinical Research, LLC - Jupiter
- Ocala Kidney Group - Ocala
- Pines Clinical Research, Inc. - Pembroke Pines
California
- Tower Nephrology Medical Group - Los Angeles
- Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles - Los Angeles
- Apex Research of Riverside - Riverside
- American Institute of Research - Whittier
Colorado
- University of Colorado Denver - Aurora
- Western Nephrology - Westminster
Georgia
- Kidney Care Associates, LLC - Augusta
- Atlanta Nephrology Referral Center - Decatur
Massachusetts
- Tufts Medical Center - Boston
- Pioneer Valley Nephrology - Holyoke
Arizona
- Southwest Clinical Research Institute, LLC - Tempe
Illinois
- Circle Medical Management - Chicago
Indiana
- Nephrology Specialists, PC - Michigan City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01191255 record still lists
NCT01191255 is an interventional study that assigns participants to a tested intervention. The registered 441 participants enrollment target is mid-sized for trials with a published cap, below the 563-participant average among 18 other Kidney Failure trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Kidney Failure appearing as the primary indexed condition, and to 1 intervention - of which ferric citrate, ca acetate, sevelamer carbonate, placebo is the first listed.
NCT01191255 names 20 study sites across 10 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01191255 about?
NCT01191255 is a clinical study titled "A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis". 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.
What is the current status of trial NCT01191255?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 441 participants. The study started on 2010-10. Estimated completion is 2013-02.
What conditions does trial NCT01191255 study?
This clinical trial studies the following conditions: Kidney Failure, Hyperphosphatemia.
What interventions are being tested in trial NCT01191255?
The interventions under investigation include: ferric citrate, ca acetate, sevelamer carbonate, placebo (DRUG).
Who is sponsoring clinical trial NCT01191255?
This trial is sponsored by Keryx Biopharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01191255 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01191255's enrollment target sits among peer trials
441 6th of 18 higher than 13 of 18 other Kidney Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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