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NCT01554982 · ClinicalTrials.gov registry record · Phase 3

A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

A Phase 3 study, sponsored by Keryx Biopharmaceuticals.

Completed
Registry status
Phase 3
Development phase
168
Enrollment target

NCT01554982: Completed Phase 3 study, sponsored by Keryx Biopharmaceuticals.

NCT01554982 is a Phase 3 study that has completed, run by Keryx Biopharmaceuticals. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01554982, a Phase 3 study, has completed, sponsored by Keryx Biopharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
168 participants
Enrollment target

Study 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.

Primary Outcome

Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).

Interventions

  • DRUG ferric citrate

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2012-08
Est. Completion 2014-08
Phase Phase 3
Keryx Biopharmaceuticals

9 total trials

What the finished NCT01554982 record still lists

NCT01554982 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which ferric citrate is the first listed.

NCT01554982 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01554982 about?

NCT01554982 is a clinical study titled "A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis". 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.

What is the current status of trial NCT01554982?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2012-08. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01554982?

The interventions under investigation include: ferric citrate (DRUG).

Who is sponsoring clinical trial NCT01554982?

This trial is sponsored by Keryx Biopharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01554982's enrollment target sits among peer trials

168 1459th of 2000 higher than 538 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01554982, the US trial registry maintained by the National Library of Medicine. NCT01554982 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.