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

Primary Purpose

Hemodialysis, Chronic Renal Failure, Anemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
r-HuEPO
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring hemodialysis, erythropoietin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    0800

    1500

    2200

    Arm Description

    r-HuEPO administered at 0800 hrs

    r-HuEPO administered at 1500 hrs

    r-HuEPO administered at 2200 hrs

    Outcomes

    Primary Outcome Measures

    Time for hematocrit to rise

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2008
    Last Updated
    August 29, 2008
    Sponsor
    Sunnybrook Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00744445
    Brief Title
    Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
    Official Title
    Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1993 (undefined)
    Primary Completion Date
    August 1998 (Actual)
    Study Completion Date
    August 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sunnybrook Health Sciences Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemodialysis, Chronic Renal Failure, Anemia
    Keywords
    hemodialysis, erythropoietin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0800
    Arm Type
    Active Comparator
    Arm Description
    r-HuEPO administered at 0800 hrs
    Arm Title
    1500
    Arm Type
    Active Comparator
    Arm Description
    r-HuEPO administered at 1500 hrs
    Arm Title
    2200
    Arm Type
    Active Comparator
    Arm Description
    r-HuEPO administered at 2200 hrs
    Intervention Type
    Drug
    Intervention Name(s)
    r-HuEPO
    Intervention Description
    r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
    Primary Outcome Measure Information:
    Title
    Time for hematocrit to rise

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Georg Bjarnason, MD, FRCPC
    Organizational Affiliation
    Sunnybrook Health Sciences Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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