TY - JOUR
T1 - Treatment of the anemia of predialysis patients with recombinant human erythropoietin
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.
AU - Pincus, T. P.
N1 - Funding Information:
From the *Medical Service, Veterans Administration Medical Center, and the Department of Medicine, Vanderbilt University . Medical Center, Nashville, Tennessee, and tOrtho Pharmaceutical Corporation, Raritan, New Jersey. Supported by VA Medical Research Funds, by US Public Health Service Grants AM-15555, T 32-07186 and RR-95, and by Ortho Pharmaceutical Corporation. The authors thank JoAnn Alexander, RN, BSN, for data collection and nursing care and Thelma Knickerbocker for manuscript preparation. Dr. V. G. Dev performed the cytogenetic studies. Reprint requests: William J. Stone, MD, VA Medical Center, 1310 24th Avenue South, Nashville, TN 37212.
PY - 1988
Y1 - 1988
N2 - 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.
AB - 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.
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U2 - 10.1097/00000441-198809000-00005
DO - 10.1097/00000441-198809000-00005
M3 - Article
C2 - 3177433
AN - SCOPUS:0023806006
SN - 0002-9629
VL - 296
SP - 171
EP - 179
JO - American Journal of the Medical Sciences
JF - American Journal of the Medical Sciences
IS - 3
ER -