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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01191255
The ClinicalTrials.gov registry entry for NCT01191255 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 563-participant average among 18 other Kidney Failure trials with a reported enrollment target (22% lower). The listed sponsor is Keryx Biopharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.