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

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ClinicalTrials.gov Identifier: NCT00744445
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : September 1, 2008
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Chronic Renal Failure Anemia Drug: r-HuEPO Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
Study Start Date : October 1993
Actual Primary Completion Date : August 1998
Actual Study Completion Date : August 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 0800
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.
Active Comparator: 1500
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.
Active Comparator: 2200
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.



Primary Outcome Measures :
  1. Time for hematocrit to rise


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744445


Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Georg Bjarnason, MD, FRCPC Sunnybrook Health Sciences Centre

Responsible Party: Dr. G.A. Bjarnason, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00744445     History of Changes
Other Study ID Numbers: 022-1994
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: September 1, 2008
Last Verified: August 2008

Keywords provided by Sunnybrook Health Sciences Centre:
hemodialysis
erythropoietin

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics