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

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 2

Conditions: Anemia; Hemodialysis; Chronic Renal Failure

Treatments: Drug: r-HuEPO

Study type: Interventional

Funder types: Other

Identifiers

NCT00744445

022-1994

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

0800

Active Comparator group

Description:

r-HuEPO administered at 0800 hrs

Treatment:

Drug: r-HuEPO

1500

Active Comparator group

Description:

r-HuEPO administered at 1500 hrs

Treatment:

Drug: r-HuEPO

2200

Active Comparator group

Description:

r-HuEPO administered at 2200 hrs

Treatment:

Drug: r-HuEPO