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Completed

NCT Number: NCT00744445

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

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.

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Key information

Conditions

Hemodialysis Anemia Chronic Disease Chronic Renal Failure Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

r-HuEPO

Drug

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

Primary outcomes

  1. Time for hematocrit to rise

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
1993
Primary completion
1998
Study completion
1998
First posted
Sep 1, 2008
Registry last updated
Sep 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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