NCT00004496

Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Texas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Acute Renal Failure

Interventions

Type	Name	Description
DRUG	alpha-melanocyte stimulating hormone

Timeline

• Start date: 1999-02-01
• Completion: 2003-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

2 sites across 1 country: United States