Treatment of the anemia of predialysis patients with recombinant human erythropoietin: A randomized, placebo-controlled trial

W. J. Stone, S. E. Graber, S. B. Krantz, E. N. Dessypris, V. L. O'Neil, N. J. Olsen, T. P. Pincus

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Abstract

Recombinant human erythropoietein (r-HuEPO) was administered in two phases to 12 patients with chronic renal insufficiency (creatinine clearances of 0.17-0.51 ml/second [10-30 ml/minute]) and uremic anemia. In addition to the routine tests done as part of a multicenter clinical trial, our patients had serial red cell mass measurements, quantitation of bone marrow stem cells, and marrow cytogenetic analysis. During the first eight weeks (acute phase), an equal number of patients was randomized to placebo or one of three doses of r-HuEPO (50, 100 or 150 unit/kg intravenously three times weekly). All three patients receiving 150 unit/kg responded by increasing their packed cell volume (PCV) to the normal range within eight weeks. There were lesser responses in PCV at the two lower doses of r-HuEPO and no response in the placebo group. The 51Cr red cell mass also increased significantly in a dose-related manner in patients receiving r-HuEPO but did not change in the placebo group. Marrow studies revealed increases in erythroid, megakaryocyte, and granulocyte-monocyte progenitor cells in those patients on r-HuEPO, but no mutagenic effects were seen. Subsequently, ten patients received open label r-HuEPO. During this maintenance phase, all ten achieved or maintained a normal PCV. Several adverse events occurred, but none were definitely linked to r-HuEPO. Recombinant human erythropoietin is an effective and potent treatment of anemia caused by renal failure.

Original languageEnglish (US)
Pages (from-to)171-179
Number of pages9
JournalAmerican Journal of the Medical Sciences
Volume296
Issue number3
DOIs
StatePublished - Jan 1 1988

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Erythropoietin
Anemia
Randomized Controlled Trials
Placebos
Cell Size
Erythrocyte Volume
Therapeutics
Bone Marrow
Granulocyte Precursor Cells
Megakaryocytes
Cytogenetic Analysis
Chronic Renal Insufficiency
Bone Marrow Cells
Multicenter Studies
Renal Insufficiency
Monocytes
Creatinine
Reference Values
Stem Cells
Maintenance

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Stone, W. J. ; Graber, S. E. ; Krantz, S. B. ; Dessypris, E. N. ; O'Neil, V. L. ; Olsen, N. J. ; Pincus, T. P. / Treatment of the anemia of predialysis patients with recombinant human erythropoietin : A randomized, placebo-controlled trial. In: American Journal of the Medical Sciences. 1988 ; Vol. 296, No. 3. pp. 171-179.
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Treatment of the anemia of predialysis patients with recombinant human erythropoietin : A randomized, placebo-controlled trial. / Stone, W. J.; Graber, S. E.; Krantz, S. B.; Dessypris, E. N.; O'Neil, V. L.; Olsen, N. J.; Pincus, T. P.

In: American Journal of the Medical Sciences, Vol. 296, No. 3, 01.01.1988, p. 171-179.

Research output: Contribution to journalArticle

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T2 - A randomized, placebo-controlled trial

AU - Stone, W. J.

AU - Graber, S. E.

AU - Krantz, S. B.

AU - Dessypris, E. N.

AU - O'Neil, V. L.

AU - Olsen, N. J.

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