Etiocholodione (ED) is an oral pro-drug for etiocholanolone (ET). ED and ET stimulate hematopoiesis by a direct action on hematopoietic stem cells. Patients with chronic renal failure have an anemia which is mainly due to lack of erythropoietin. This study is designed to determine the pharmacokinetics of a single dose of ED in patients with varying degrees of renal failure. The patients will be monitored for any adverse side effects. The study may lead to a phase II/III study to determine the utility of ED in anemia of renal failure. A total of 10 patients were screened. Three failed the screen due to use of street drugs. One patient was lost due to scheduling difficulty and one was rejected due to a high serum GGT level. Five patients have completed the study. Three patients were on dialysis and two had lesser degree of renal failure (2 gpB, 1gpC). The serum levels peaked at 5-12 ng ml at 2-4 hrs post dose. The levels then fell between 2 to 5 ng/ml. As the assay system may not be sensitive at these low levels, the dose of oral ED has therefore been increased to 1200 ng after approval from the IRB.
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