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Recombinant Human Erythropoietin Treatment in Pre-Dialysis Patients
A Double-Blind Placebo-Controlled Trial
- Victoria S. Lim, MD;
- Richard L. DeGowin, MD;
- Donald Zavala, MD;
- Peter T. Kirchner, MD;
- Robert Abels, MD;
- Paul Perry, PhD; and
- Jerry Fangman
Abstract
Study Objective: To determine the efficacy and safety of recombinant human erythropoietin (r-HuEPO) in predialysis renal patients.
Design: Randomized, double-blind, placebo-controlled trial for 8 weeks.
Setting: Inpatient and outpatient facility in the Clinical Research Center of a university-based hospital.
Patients: Fourteen adult subjects with renal insufficiency (mean serum creatinine, 473 µmol/L ± 61 [6.2 µ 0.8 mg/dL] ) and anemia (mean hematocrit, 0.27 ± 0.01).
Interventions: Recombinant human erythropoietin, 50, 100, or 150 IU/kg body weight or placebo given intravenously three times per week.
Measurements and Main Results: Subjects who received active r-HuEPO showed a dose-dependent rise in hematocrit; mean hematocrit increased 41% from 0. 27 ± 0.01 to 0.38 ± 0.01. At the same time, erythrocyte mass rose 43% from 13.7 ± 0.6 mL/kg in the baseline state to 19.6 ± 1.0 mL/kg after treatment. Maximal oxygen consumption during exercise increased 9% from 16.0 mL/min · kg ± 1.8 to 17.5 mL/min · kg ± 1.9.
Conclusions: Recombinant human erythropoietin is effective and safe in ameliorating the anemia of pre-dialysis patients.
Article and Author Information
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From the University of Iowa College of Medicine and the University of Iowa College of Pharmacy, Iowa City, Iowa; and Ortho Pharmaceutical Corporation, Raritan, New Jersey. For current author addresses, see end of text.
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Grant Support: Supported in part by the Ortho Pharmaceutical Corporation and by grant RR59 of the General Clinical Research Center Program, Division of Research Resources, National Institutes of Health.
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Requests for Reprints: Victoria S. Lim, MD, Division of Nephrology, Department of Internal Medicine, Iowa City, IA 52242.
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Current Author Addresses: Drs. Lim, DeGowin, and Zavala, and Mr. Fangman: Department of Internal Medicine, University of Iowa College of Medicine, Iowa City, IA 52242.
Dr. Kirchner: Department of Radiology, University of Iowa College of Medicine, Iowa City, IA 52242.
Dr. Abels: Ortho Pharmaceutical Corporation, Raritan, NJ 08869.
Dr. Perry: College of Pharmacy, University of Iowa, Iowa City, IA 52242.
- ©1989 American College of Physicians
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