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Sponsored by: |
Affymax |
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Information provided by: | Affymax |
ClinicalTrials.gov Identifier: | NCT00453973 |
To evaluate the safety and tolerability of Hematide™ for the maintenance of hemoglobin (Hgb) in patients with Chronic Kidney Disease (CKD).
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 Study |
Official Title: | An Open-Label, Multi-Center, Extension Study to Evaluate the Safety and Tolerability of Hematide™ Injection for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease |
Estimated Enrollment: | 125 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Hematide™
Injection
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Research Facility | |
Varna, Bulgaria, 9010 | |
Research Facility | |
Rousse, Bulgaria, 7002 | |
Research Facility | |
Pleven, Bulgaria, 5800 | |
Research Facility | |
Plovdiv, Bulgaria, 4003 | |
Research Facility | |
Veliko Tarnovo, Bulgaria, 5000 | |
Research Facility | |
Burgas, Bulgaria, 8000 | |
Poland | |
Research Facility | |
Łódź, Poland, 90-153 | |
Research Facility | |
Kraków, Poland, 31-501 | |
Research Facility | |
Białystok, Poland, 15-540 | |
Research Facility | |
Kraków, Poland, 31-826 | |
Research Facility | |
Katowice, Poland, 40-027 | |
Romania | |
Research Facility | |
Iasi, Romania, 700506 | |
Research Facility | |
Timisoara, Romania, 300736 | |
Research Facility | |
Arad, Romania, 310017 | |
Research Facility | |
Bacau, Romania, 600114 | |
Research Facility | |
Bucuresti, Romania, 014461 | |
United Kingdom | |
Research Facility | |
London, United Kingdom, SES 9RS | |
Research Facility | |
London, United Kingdom, SW17 0QT | |
Research Facility | |
Croydon, United Kingdom, CR7 7YE | |
Research Facility | |
Swansea, United Kingdom, SA6 6NL | |
Research Facility | |
London, United Kingdom, E1 1BB | |
Research Facility | |
Derby, United Kingdom, DE22 3NE |
Study Director: | Chief Medical Officer | Affymax, Inc. |
Responsible Party: | Affymax ( Chief Medical Officer ) |
Study ID Numbers: | AFX01-10 |
Study First Received: | March 27, 2007 |
Last Updated: | May 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00453973 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Anemia Chronic Kidney Disease |
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 |