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Sponsored by: |
Affymax |
---|---|
Information provided by: | Affymax |
ClinicalTrials.gov Identifier: | NCT00434330 |
To determine the dose ranges of Hematide™ administered intravenously (IV) or subcutaneously (SC) in hemodialysis (HD) patients previously treated with Epoetin.
Condition | Intervention | Phase |
---|---|---|
Anemia Chronic Kidney Disease |
Drug: Hematide™ |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Open-Label, Multi-Center, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Hematide™ for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin |
Enrollment: | 90 |
Study Start Date: | December 2006 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Hematide™
Injection
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Research Facility | |
Sofia, Bulgaria, 1527 | |
Research Facility | |
Pleven, Bulgaria, 5800 | |
Research Facility | |
Sofia, Bulgaria, 1606 | |
Research Facility | |
Sofia, Bulgaria, 1705 | |
Research Facility | |
Varna, Bulgaria, 9010 | |
Research Facility | |
Plovdiv, Bulgaria, 4003 | |
Research Facility | |
Veliko Tarnovo, Bulgaria, 5000 | |
Research Facility | |
Burgas, Bulgaria, 8000 | |
Research Facility | |
Rousse, Bulgaria, 7002 | |
Romania | |
Research Facility | |
Bucuresti, Romania | |
Research Facility | |
Timisoara, Romania, 300736 | |
Research Facility | |
Iasi, Romania, 700506 | |
Research Facility | |
Arad, Romania, 310017 | |
Research Facility | |
Bacau, Romania, 600114 | |
Research Facility | |
Bucuresti, Romania | |
United Kingdom | |
Research Facility | |
London, United Kingdom, SE5 9RS |
Study Chair: | Chief Medical Officer | Affymax, Inc. |
Responsible Party: | Affymax, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | AFX01-07 |
Study First Received: | February 12, 2007 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00434330 History of Changes |
Health Authority: | Romania: National Medicines Agency; United Kingdom: Department of Health; Bulgaria: Bulgarian Drug Agency |
Anemia Chronic Kidney Disease Hemodialysis |
Epoetin Alfa Signs and Symptoms Renal Insufficiency Urologic Diseases Hematologic Diseases |
Renal Insufficiency, Chronic Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Hematologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Anemia Kidney Diseases Kidney Failure |