Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
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|
|Estimated Study Completion Date:||September 2003|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004496
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75235-8897|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Study Chair:||Robert Toto||University of Texas|