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NCT00597584 · ClinicalTrials.gov registry record · Phase 3

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

A Phase 3 study, sponsored by Affymax.

Completed
Registry status
Phase 3
Development phase
823
Enrollment target

NCT00597584: Completed Phase 3 study, sponsored by Affymax.

NCT00597584 is a Phase 3 study that has completed, run by Affymax. The registered enrollment target is 823 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00597584, a Phase 3 study, has completed, sponsored by Affymax.

COMPLETED
Registry status
Phase 3
Development phase
823 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

Primary Outcome

The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.

Interventions

  • DRUG peginesatide
  • DRUG Epoetin alfa or Epoetin beta

Trial Details

FieldValue
Enrollment Target 823 participants
Start Date 2007-10
Est. Completion 2010-01
Phase Phase 3
Affymax

6 total trials

What the finished NCT00597584 record still lists

NCT00597584 is an interventional study that assigns participants to a tested intervention. The registered 823 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which peginesatide is the first listed.

NCT00597584 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00597584 about?

NCT00597584 is a clinical study titled "Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis". The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

What is the current status of trial NCT00597584?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 823 participants. The study started on 2007-10. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00597584?

The interventions under investigation include: peginesatide (DRUG), Epoetin alfa or Epoetin beta (DRUG).

Who is sponsoring clinical trial NCT00597584?

This trial is sponsored by Affymax, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00597584's enrollment target sits among peer trials

823 402nd of 2000 higher than 1,599 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 NCT00597584, the US trial registry maintained by the National Library of Medicine. NCT00597584 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.