Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

• Status: Completed
• Trial end date: 1998-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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