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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00093015 |
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa on mortality and cardiovascular morbidity in patients with chronic kidney disease and type 2 diabetes.
Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD
Condition | Intervention | Phase |
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Kidney Disease Diabetes Mellitus Anemia |
Drug: Placebo Drug: darbepoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Trial to Reduce Cardiovascular Events With Aranesp® Therapy |
Estimated Enrollment: | 4000 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Active Comparator |
Drug: darbepoetin alfa
Starting dose : 0.75 mcg/kg SC Q2W; subsequent doses titrated to achieve Hb target of 13.0 g/dL
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Placebo: Placebo Comparator |
Drug: Placebo
Volume and dose frequency changes resembling dosing in the active treatment group
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Hemoglobin less than or equal to 11 g/dL - History of Chronic Kidney Disease - eGFR greater than or equal to 20 mL/min and less than or equal to 60 mL/min - Tsat greater than 15% Exclusion Criteria: - Uncontrolled hypertension - Erythropoietic protein use within 12 weeks of randomization
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010184, TREAT |
Study First Received: | September 28, 2004 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00093015 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Urologic Diseases Hematinics Darbepoetin alfa Diabetes Mellitus Anemia |
Endocrine System Diseases Endocrinopathy Kidney Diseases Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Urologic Diseases Hematinics Therapeutic Uses Hematologic Agents Darbepoetin alfa |
Diabetes Mellitus Endocrine System Diseases Kidney Diseases Glucose Metabolism Disorders Pharmacologic Actions |