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

October 18, 1999
June 23, 2005
February 1999
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Complete list of historical versions of study NCT00004496 on ClinicalTrials.gov Archive Site
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Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
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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.

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.

Interventional
Phase 1
Masking: Double-Blind
Primary Purpose: Treatment
Acute Renal Failure
Drug: alpha-melanocyte stimulating hormone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
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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)

Both
18 Years to 80 Years
No
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United States
 
NCT00004496
199/14286, UTSMC-FDR001552, UTSMC-129447100
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FDA Office of Orphan Products Development
University of Texas
Study Chair: Robert Toto University of Texas
FDA Office of Orphan Products Development
August 1999

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