Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity - Full Text View

Sponsored by:	Sunnybrook Health Sciences Centre
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00744445

Purpose

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.

Condition	Intervention	Phase
Hemodialysis Chronic Renal Failure Anemia	Drug: r-HuEPO	Phase II

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

Time for hematocrit to rise [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	October 1993
Study Completion Date:	August 1998
Primary Completion Date:	August 1998 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0800: Active Comparator r-HuEPO administered at 0800 hrs	Drug: r-HuEPO r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
1500: Active Comparator r-HuEPO administered at 1500 hrs	Drug: r-HuEPO r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
2200: Active Comparator 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744445

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

Principal Investigator:

Georg Bjarnason, MD, FRCPC

Sunnybrook Health Sciences Centre

More Information

Responsible Party:	Sunnybrook Health Sciences Centre ( Dr. G.A. Bjarnason )
Study ID Numbers:	022-1994
Study First Received:	August 29, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744445
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:

hemodialysis
erythropoietin

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009