A Phase 2 interventional study of r-HuEPO in Hemodialysis, Chronic Renal Failure and Anemia, sponsored by Sunnybrook Health Sciences Centre. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-01.
Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Treatment
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.
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 46 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
r-HuEPO administered at 0800 hrs
Drug: r-HuEPO
r-HuEPO administered at 1500 hrs
Drug: r-HuEPO
r-HuEPO administered at 2200 hrs
Drug: r-HuEPO
r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
Time for hematocrit to rise
No study locations are listed for this record.
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre