Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
|ClinicalTrials.gov Identifier: NCT00004496|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Renal Failure||Drug: alpha-melanocyte stimulating hormone||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Study Start Date :||February 1999|
|Study Completion Date :||September 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|