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A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
NCT01191255 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Keryx Biopharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01191255 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01191255?
The interventions under investigation include: ferric citrate, ca acetate, sevelamer carbonate, placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01191255?
This trial is sponsored by Keryx Biopharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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