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NCT00597753 · 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 of Chronic Kidney Disease and Anemia, sponsored by Affymax.
- Completed
- Registry status
- Phase 3
- Development phase
- 803
- Enrollment target
- 20
- Study locations
NCT00597753: Completed Phase 3 study of Chronic Kidney Disease and Anemia, sponsored by Affymax.
NCT00597753 is a Phase 3 study of Chronic Kidney Disease and Anemia that has completed, run by Affymax. The registered enrollment target is 803 participants, below the 3,199-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00597753, a Phase 3 study of Chronic Kidney Disease and Anemia, has completed, sponsored by Affymax.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 803 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the 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.
Conditions Studied
Interventions
- DRUG Epoetin Alfa
- DRUG peginesatide
Study Locations (20)
California
- Research Facility - Fairfield
- Research Facility - Granada Hills
- Research Facility - Los Alamitos
- Research Facility - Los Angeles
- Research Facility - Los Angeles
- Research Facility - Los Angeles
- Research Facility - Lynwood
- Research Facility - Monterey Park
- Research Facility - Mountain View
- Research Facility - Paramount
- Research Facilities (2) - San Diego
- Research Facility - San Dimas
- Research Facility - Whittier
Florida
- Research Facility - Hudson
- Research Facility - Ocala
- Research Facility - Orlando
- Research Facility - Orlando
Arkansas
- Research Facility - Paragould
Colorado
- Research Facility - Denver
Connecticut
- Research Facility - Middlebury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 803 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00597753 record still lists
NCT00597753 is an interventional study that assigns participants to a tested intervention. The registered 803 participants enrollment target is mid-sized for trials with a published cap, below the 3,199-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (75% lower).
The record links to 3 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Epoetin Alfa is the first listed.
NCT00597753 names 20 study sites across 5 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00597753 about?
NCT00597753 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 the 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 NCT00597753?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 803 participants. The study started on 2007-09. Estimated completion is 2010-01.
What conditions does trial NCT00597753 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Anemia, Chronic Renal Failure.
What interventions are being tested in trial NCT00597753?
The interventions under investigation include: Epoetin Alfa (DRUG), peginesatide (DRUG).
Who is sponsoring clinical trial NCT00597753?
This trial is sponsored by Affymax, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00597753 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00597753's enrollment target sits among peer trials
803 19th of 101 higher than 83 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease 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.
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