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Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
NCT00597753 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00597753
The ClinicalTrials.gov registry entry for NCT00597753 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 803 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Affymax, 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 3 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions — of which Epoetin Alfa 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: NCT00597753 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arkansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00597753?
The interventions under investigation include: Epoetin Alfa (DRUG), peginesatide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00597753?
This trial is sponsored by Affymax, 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 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.
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