Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|