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Sponsored by: |
Sunnybrook Health Sciences Centre |
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Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00744445 |
The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.
Condition | Intervention | Phase |
---|---|---|
Hemodialysis Chronic Renal Failure Anemia |
Drug: r-HuEPO |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity |
Enrollment: | 46 |
Study Start Date: | October 1993 |
Study Completion Date: | August 1998 |
Primary Completion Date: | August 1998 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
0800: Active Comparator
r-HuEPO administered at 0800 hrs
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Drug: r-HuEPO
r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
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1500: Active Comparator
r-HuEPO administered at 1500 hrs
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Drug: r-HuEPO
r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
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2200: Active Comparator
r-HuEPO administered at 2200 hrs
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Drug: r-HuEPO
r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
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This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sunnybrook Health Sciences Centre ( Dr. G.A. Bjarnason ) |
Study ID Numbers: | 022-1994 |
Study First Received: | August 29, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00744445 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
hemodialysis erythropoietin |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic Therapeutic Uses |
Hematologic Agents Kidney Failure, Chronic Kidney Diseases Pharmacologic Actions Kidney Failure |