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

August 29, 2008 updated by: Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

46

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time for hematocrit to rise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Georg Bjarnason, MD, FRCPC, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1993

Primary Completion (Actual)

August 1, 1998

Study Completion (Actual)

August 1, 1998

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

September 1, 2008

Last Update Submitted That Met QC Criteria

August 29, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022-1994

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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