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

Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemodialysis; Chronic Renal Failure; Anemia

Intervention: r-HuEPO (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sunnybrook Health Sciences Centre

Official(s) and/or principal investigator(s):
Georg Bjarnason, MD, FRCPC, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time for hematocrit to rise

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: October 1993
Last updated: August 29, 2008

Page last updated: August 23, 2015

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