Status:
COMPLETED
Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Hemodialysis
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 level...
Eligibility Criteria
Inclusion
- Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
- Serum ferritin level \> 200 micrograms/L and transferrin saturation \> 15%
- Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
- Prior therapy with r-HuEPO
- An adequate program of dialysis established
- Informed consent signed
Exclusion
- Adocumented cause of anemia other than chronic renal disease
- Symptoms of unstable coronary artery disease
- Poorly controled hypertension
- Known seizure disorder
- Other active inflammatory or infective disorders
- Other disorders that may diminish the response of the bone marrow to r-HuEPO
Key Trial Info
Start Date :
October 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1998
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00744445
Start Date
October 1 1993
End Date
August 1 1998
Last Update
September 1 2008
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