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

Acute Renal Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004496
• Other study ID #: 199/14286
• Secondary ID: UTSMC-FDR001552U
• Status: Completed
• Phase: Phase 1
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: February 1999
• Est. completion date: September 2003

Study information

• Verified date: August 1999
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Group 1: Patients on chronic hemodialysis

Group 2: Patients at high risk of developing acute renal failure (ARF) after cadaveric renal transplantation Received high risk allograft Cadaveric kidneys with greater than 24 hours of cold ischemia time Donor had rising creatinine before organ procurement Donor over 60 years

Group 3: Patients with ischemic ARF due to hypotension, surgery, or trauma ARF severity index 20-60% Creatinine clearance 12-14 mL/min Rising creatinine of at least 0.5 mg/dL per day for 2 days without evidence of recovery despite standard supportive care No drug or contrast induced renal failure No oliguric renal failure (creatinine clearance 3-4 mL/min) No prior chronic renal failure Baseline creatinine greater than 2.5 mg/dL (males) or 2.0 mg/dL (females) No ARF due to bacterial or fungal sepsis, nephrotoxins, acute tubulointerstitial nephritis, cyclosporine toxicity, bilateral renal vascular disease, or systemic diseases (hepatorenal syndrome, glomerulonephritis, renal vasculitis, etc.)

--Prior/Concurrent Therapy--

Group 1: No recent immunosuppressive therapy Group 2 and 3: No prior renal transplantation No prior alpha-MSH Group 3: No prior dialysis for this episode of ARF No anticipated need for dialysis for at least 24 hours At least 12 hours since prior diuretics, mannitol, or dopamine At least 14 days since prior immunosuppressive drugs

--Patient Characteristics--

No recent infection No known reaction to Terumo T175 dialyzer Not a prisoner Not pregnant or nursing No allergy to drugs used in study Not mentally impaired Group 3: No severe nonrenal medical condition that would interfere with the study (e.g., terminal cancer)

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Drug:
• alpha-melanocyte stimulating hormone

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas

Country where clinical trial is conducted

United States,