Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure
Recruitment status was Recruiting
|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|
|Brief Title ICMJE||Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure|
|Official Title ICMJE||Not Provided|
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.
|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 Status ICMJE||Recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PROTOCOL ENTRY CRITERIA:
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.)
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
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)
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Not Provided|
|Location Countries ICMJE||United States|
|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|
|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