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Recombinant Human Erythropoietin in Anemic Patients with End-Stage Renal Disease: Results of a Phase III Multicenter Clinical Trial

Joseph W. Eschbach, MD; Mohamed H. Abdulhadi, MD; Jeffrey K. Browne, PhD; Barbara G. Delano, MD; Michael R. Downing, PhD; Joan C. Egrie, PhD; Roger W. Evans, PhD; Eli A. Friedman, MD; Stanley E. Graber, MD; N. Rebecca Haley, MD; Stephen Korbet, MD; Sanford B. Krantz, MD; A. Peter Lundin, MD; Allen R. Nissenson, MD; David A. Ogden, MD; Emil P. Paganini, MD; Barbara Rader, MEd.; Edwin A. Rutsky, MD; John Stivelman, MD; William J. Stone, MD; Paul Teschan, MD; John C. Van Stone, MD; David B. Van Wyck, MD; Kenneth Zuckerman, MD; and John W. Adamson, MD
[+] Article, Author, and Disclosure Information

Grant Support: Supported in part by Amgen, Inc., Thousand Oaks, California.

Requests for Reprints: Michael Downing, PhD, Amgen, Inc., 1900 Oak Terrace Lane, Thousand Oaks, CA 91320.

Current Author Addresses: Drs. Eschbach and Haley: Division of Hematology, RM-10, Department of Medicine, University of Washington, Seattle, WA 98195.

Drs. Abdulhadi and Paganini: Section of Dialysis and Extracorporeal Therapy, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44106.

Drs. Browne, Downing, and Egrie: Amgen, Inc., 1900 Oak Terrace Lane, Thousand Oaks, CA 91320.

Drs. Delano, Friedman, and Lundin: Division of Renal Disease, Department of Medicine, State University of New York Health Science Center at Brooklyn, 470 Clarkson Avenue, Box 52, Brooklyn, NY 11203.

Dr. Evans and Ms. Rader: Battelle, Human Affairs Research Center, P.O. Box C-5395, 4000 N.E. 41st Street, Seattle, WA 98105.

Drs. Graber and Krantz: Division of Hematology, Department of Medicine, Vanderbilt University, Nashville, TN 37232.

Dr. Korbet: Section of Nephrology, Department of Medicine, Rush-Presbyterian-St. Luke's Medical Center, 1653 West Congress Parkway, Chicago, IL 60612.

Dr. Nissenson: Division of Nephrology, Department of Medicine, UCLA School of Medicine, Los Angeles, CA 90024. Drs. Ogden and Van Wyck: Department of Internal Medicine, Section of Renal Disease, The University of Arizona Health Sciences Center, Tucson, AZ 85724.

Dr. Rutsky: University of Alabama at Birmingham, Department of Medicine/Division of Nephrology, Birmingham, AL 35294.

Dr. Stivelman: Department of Medicine, Emory University School of Medicine, 69 Butler Street, S.E., Atlanta, GA 30303.

Drs. Stone and Teschan: Nashville Veterans Affairs Medical Center, 1310-24th Avenue, South, Nashville, TN 37212.

Dr. Van Stone: Department of Medicine, Division of Nephrology, University of Missouri Medical School, 18005 E. Walnut, Columbia, MO 65212.

Dr. Zuckerman: University of Alabama at Birmingham, Division of Hematology/Oncology, Department of Medicine, Birmingham, AL 35294. Dr. Adamson: The New York Blood Center, 310 East 67th Street, New York, NY 10021.

© 1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;111(12):992-1000. doi:10.7326/0003-4819-111-12-992
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Study Objective: To determine the effectiveness and safety of recombinant human erythropoietin (rHuEpo).

Patients: Hemodialysis patients (333) with uncomplicated anemia (hematocrit < 0.30). All received rHuEpo intravenously, three times per week at 300 or 150 U/kg body weight, which was then reduced to 75 U/kg and adjusted to maintain the hematocrit at 0.35 ± 0.03 (SD).

Results: The baseline hematocrit (0.223 ± 0.002) increased to 0.35, more than 0.06 over baseline within 12 weeks in 97.4% of patients. Erythrocyte transfusions (1030 within the 6 months before rHuEpo therapy) were eliminated in all patients within 2 months of therapy. Sixty-eight patients with iron overload had a 39% reduction in serum ferritin levels after 6 months of therapy. The median maintenance dose of rHuEpo was 75 U/kg, three times per week (range, 12.5 to 525 U/kg). Nonresponders had complicating causes for anemia: myelofibrosis, osteitis fibrosa, osteomyelitis, and acute or chronic blood loss. Adverse effects included myalgias, 5%; iron deficiency, 43%; increased blood pressure, 35%; and seizures, 5.4%. The creatinine, potassium, and phosphate levels increased slightly but significantly. The platelet count increased slightly but there was no increase in clotting of vascular accesses.

Conclusions: The anemia of hemodialysis patients is corrected by rHuEpo resulting in the elimination of transfusions, reduction in iron overload, and improved quality of life. Iron stores and blood pressure must be monitored and treated to maintain the effectiveness of rHuEpo and to minimize the threat of hypertensive encephalopathy.





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