Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
Recruitment status was Recruiting
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.
|Study Design:||Masking: Double-Blind
Primary Purpose: Treatment
|Study Start Date:||February 1999|
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.
|United States, Texas|
|Baylor University Medical Center||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Andrew Z. Fenves 214-820-2468|
|University of Texas Southwestern Medical Center at Dallas||Recruiting|
|Dallas, Texas, United States, 75235-8897|
|Contact: Robert Toto 214-358-2300|
|Study Chair:||Robert Toto||University of Texas|