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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
[+] Article, Author, and Disclosure Information

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.

Requests for Reprints: Victoria S. Lim, MD, Division of Nephrology, Department of Internal Medicine, Iowa City, IA 52242.

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 PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;110(2):108-114. doi:10.7326/0003-4819-110-2-108
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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.





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