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Home > "P" Clinical Trials Conditions > Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients with Acute Renal Failure  Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients with Acute Renal Failure
Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients with Acute Renal Failure
For Condition: Acute Renal Failure
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Texas
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: 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)
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
RobertToto, Study Chair, University of Texas
University of Texas Southwestern Medical Center at Dallas *Recruiting*
Dallas, Texas, 75235-8897
United States
Recruiting Robert Toto 214-358-2300
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Andrew Fenves 214-820-2468
Additional Information:
Study ID Numbers: 199/14286; UTSMC-FDR001552,UTSMC-129447100
Study Start Date: February 1999
Record last reviewed: August 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004496
Other Acute Renal Failure Studies:
1. Renal Study
2. Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients with Acute Renal Failure
Related Studies:
Other Acute Renal Failure Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients with Acute Renal Failure
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