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

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00744445
First received: August 29, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

Resource links provided by NLM:


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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Sunnybrook Health Sciences Centre:
hemodialysis
erythropoietin

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014