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This trial is complete. It is no longer accepting participants.

NCT00004496

NCT00004496
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • (Group 1) People who are currently on regular, long-term dialysis (hemodialysis)
  • (Group 2) People who have recently received a kidney transplant from a deceased donor and are at high risk of sudden kidney failure — for example, if the donated kidney was stored for more than 24 hours before transplant, if the donor's kidney function was already declining before donation, or if the donor was over 60 years old
  • (Group 3) People who have developed sudden kidney failure caused by low blood pressure, surgery, or physical injury, with kidney function declining at a specific rate over at least 2 days and not improving with standard medical care

Who may not be able to join:

  • People whose sudden kidney failure was caused by medications, contrast dye (used in scans), bacterial or fungal infections in the bloodstream, or certain other medical conditions such as liver-kidney syndrome, kidney inflammation, or problems with the blood vessels supplying the kidneys (Group 3)
  • People who already had long-term kidney disease before their current kidney failure episode (Group 3)
  • People whose kidney function has already dropped to a very severe level requiring dialysis, or who are expected to need dialysis within the next 24 hours (Group 3)
  • People who have previously had a kidney transplant (Groups 2 and 3)
  • People who have previously been treated with the study drug (alpha-MSH) (Groups 2 and 3)
  • People who have recently taken immunosuppressive medications (medicines that lower the immune system) — timing requirements vary by group (confirm with trial site)
  • People who have recently taken diuretics ("water pills"), mannitol, or dopamine within the past 12 hours (Group 3)
  • People with a serious non-kidney medical condition, such as a terminal illness, that could interfere with the study (Group 3)
  • People who are pregnant or breastfeeding
  • People with a known allergy to any of the medications used in the study
  • People with a known reaction to a specific type of dialysis filter called the Terumo T175 dialyzer (confirm with trial site)
  • People who currently have an active infection
  • People who are currently incarcerated (prisoners)
  • People who have a cognitive impairment that would affect their ability to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
University of Texas
Registry
clinicaltrials_gov
Start date
1 February 1999

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov