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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 1999 by FDA Office of Orphan Products Development.
Recruitment status was Recruiting

Sponsor:

Collaborator:

University of Texas

Information provided by:

FDA Office of Orphan Products Development

ClinicalTrials.gov Identifier:

NCT00004496

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: August 1999

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

February 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00004496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Acute Renal Failure

Intervention ^ICMJE

Drug: alpha-melanocyte stimulating hormone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00004496

Other Study ID Numbers ^ICMJE

199/14286, UTSMC-FDR001552, UTSMC-129447100

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Study Chair:

Robert Toto

University of Texas

Information Provided By

FDA Office of Orphan Products Development

Verification Date

August 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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