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

NCT ID: NCT00744445

Last Updated: 2008-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-10-31

Study Completion Date

1998-08-31

Brief Summary

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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

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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.

Conditions

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Hemodialysis Chronic Renal Failure Anemia

Keywords

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hemodialysis erythropoietin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0800

r-HuEPO administered at 0800 hrs

Group Type ACTIVE_COMPARATOR

r-HuEPO

Intervention Type DRUG

r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.

1500

r-HuEPO administered at 1500 hrs

Group Type ACTIVE_COMPARATOR

r-HuEPO

Intervention Type DRUG

r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.

2200

r-HuEPO administered at 2200 hrs

Group Type ACTIVE_COMPARATOR

r-HuEPO

Intervention Type DRUG

r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.

Interventions

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r-HuEPO

r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Sunnybrook Health Sciences Centre

Principal Investigators

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Georg Bjarnason, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Other Identifiers

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022-1994

Identifier Type: -

Identifier Source: org_study_id