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NCT01074125 · ClinicalTrials.gov registry record · Phase 3

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

A Phase 3 study, sponsored by Keryx Biopharmaceuticals.

Completed
Registry status
Phase 3
Development phase
154
Enrollment target

NCT01074125: Completed Phase 3 study, sponsored by Keryx Biopharmaceuticals.

NCT01074125 is a Phase 3 study that has completed, run by Keryx Biopharmaceuticals. The registered enrollment target is 154 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01074125, a Phase 3 study, has completed, sponsored by Keryx Biopharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
154 participants
Enrollment target

Study Summary

This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

Primary Outcome

Mean change from baseline was calculated separately for each treatment arm (LOCF)

Interventions

  • DRUG ferric citrate

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2010-05
Est. Completion 2010-11
Phase Phase 3
Keryx Biopharmaceuticals

9 total trials

What the finished NCT01074125 record still lists

NCT01074125 is an interventional study that assigns participants to a tested intervention. The registered 154 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 (80% lower).

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

NCT01074125 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01074125 about?

NCT01074125 is a clinical study titled "A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease". This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in sm...

What is the current status of trial NCT01074125?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2010-05. Estimated completion is 2010-11.

What interventions are being tested in trial NCT01074125?

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

Who is sponsoring clinical trial NCT01074125?

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 NCT01074125's enrollment target sits among peer trials

154 1509th of 2000 higher than 491 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 NCT01074125, the US trial registry maintained by the National Library of Medicine. NCT01074125 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.