Recombinant human erythropoietin treatment in pre-dialysis patients. A double-blind placebo-controlled trial.
OBJECTIVE
To determine the efficacy and safety of recombinant human erythropoietin (r-HuEPO) in predialysis renal patients.


METHODS
Randomized, double-blind, placebo-controlled trial for 8 weeks.


METHODS
Inpatient and outpatient facility in the Clinical Research Center of a university-based hospital.


METHODS
Fourteen adult subjects with renal insufficiency (mean serum creatinine, 473 mumol/L +/- 61 [6.2 +/- 0.8 mg/dL]) and anemia (mean hematocrit, 0.27 +/- 0.01).


METHODS
Recombinant human erythropoietin, 50, 100, or 150 IU/kg body weight or placebo given intravenously three times per week.


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.
Lim
V S
VS
University of Iowa College of Medicine, Iowa City.
DeGowin
R L
RL
Zavala
D
D
Kirchner
P T
PT
Abels
R
R
Perry
P
P
Fangman
J
J
D000328:Adult; D000368:Aged; D000740:Anemia / Q000209:etiology / Q000628:therapy*; D001810:Blood Volume / Q000187:drug effects; D004311:Double-Blind Method; D004341:Drug Evaluation; D004905:Erythrocyte Aging / Q000187:drug effects; D004911:Erythrocyte Volume / Q000187:drug effects; D004921:Erythropoietin / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005080:Exercise Test; D005260:Female; D006400:Hematocrit; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D010953:Plasma Volume / Q000187:drug effects; D011897:Random Allocation; D011994:Recombinant Proteins / Q000493:pharmacokinetics / Q000627:therapeutic use
D010919:Placebos; D011994:Recombinant Proteins; D004921:Erythropoietin