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

NCT00004496 | Completed Phase 1

• 3 other identifiers: 199/14286UTSMC-FDR001552UTSMC-129447100
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Renal Failure

Keywords

acute renal failure; rare disease; renal and genitourinary disorders

Interventions

alpha-melanocyte stimulating hormone DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas: lead

Study Sites (2)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235-8897, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Rare Diseases; Urogenital Diseases

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Robert Toto

  University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: February 1, 1999
• Study Completion: September 1, 2003
• Last Updated: March 25, 2015

Record last verified: 1999-08

Locations

US (2)