Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation (STS-Transplant)

NCT06288152Sponsor: Alp SenerAAlp Sener

Actively Recruiting

View on ClinicalTrials.gov ↗

About This Study

This single-blind randomized controlled trial evaluates the efficacy of sodium thiosulfate (STS) as an additive to cold organ preservation solutions for patients undergoing kidney transplantation. Investigators aim to mitigate ischemia-reperfusion injury and delayed graft function by utilizing STS as a clinically viable hydrogen sulfide donor during the ex vivo pumping process. The study population consists of transplant recipients receiving kidneys from deceased donors, a group at high risk for reduced graft viability due to prolonged cold storage and metabolic demand. Following the intervention, participants are monitored for one year via serial blood and urine collections to assess graft function and long-term clinical outcomes.

Who Can Participate?

Inclusion Criteria

  • 18 years of age and over
  • End-Stage Renal Disease
  • Receiving a kidney transplant from a deceased donor (NDD or DCD)

Exclusion Criteria

  • Under 18 years of age
  • Inability to provide informed consent
  • Living donor kidney recipients
  • Pregnant individuals
  • Known allergy to study medication or its components (non-medicinal ingredients)
  • Multiorgan transplant patients such as simultaneous kidney pancreas or liver kidney transplants
  • Currently enrolled in another interventional transplant clinical trial, or another clinical trial that in the opinion of the QI and PI would greatly impact the results of this study.