Acute Renal Failure Clinical Trial
OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte
stimulating hormone (alpha-MSH) in patients with acute renal failure.
II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute
renal failure after renal transplantation.
III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established
ischemic acute renal failure.
IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.
PROTOCOL OUTLINE: This is a dose escalation, double blind, placebo controlled, multicenter
study.
Group 1: Patients are infused with alpha-melanocyte stimulating hormone (alpha-MSH) or
placebo over 5 minutes. A cohort of 5 patients is infused at each dose level of alpha-MSH
until the minimum effective dose (MED) and the maximum tolerated dose (MTD) are determined.
Group 2: Patients receive a single dose of the MED of alpha-MSH IV over 5 minutes at the
time anastomoses are complete. Other patients receive alpha-MSH at the MTD. Cohorts of 5
patients each are treated at the MED and the MTD.
Group 3: Patients receive alpha-MSH as in group 2. Additional dose levels are also tested.
Completion date provided represents the completion date of the grant per OOPD records
;
Masking: Double-Blind, Primary Purpose: Treatment
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