Thiosulfate-enhanced kidney preservation for deceased-donor transplants
Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation
NA · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT06288152
This trial will test whether adding sodium thiosulfate to the solution used to preserve deceased-donor kidneys helps reduce transplant-related injury and improve early kidney function in adults with end-stage renal disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06288152 on ClinicalTrials.gov |
What this trial studies
This interventional study adds sodium thiosulfate to the cold preservation solution for kidneys recovered from deceased donors (NDD or DCD) and transplanted into adult recipients. Eligible participants are adults with end-stage renal disease receiving a deceased-donor kidney at London Health Sciences Centre. The trial compares treated grafts to standard preservation with outcomes such as delayed graft function, markers of ischemia-reperfusion injury, and early graft function monitored after transplantation. Study procedures focus on the preservation and transplantation period with follow-up to record kidney function and safety events.
Who should consider this trial
Good fit: Adults (≥18) with end-stage renal disease who are receiving a deceased-donor kidney (NDD or DCD), can give informed consent, and are not undergoing multi-organ or living-donor transplant are eligible.
Not a fit: Living-donor recipients, multi-organ transplant patients, pregnant individuals, and people with known allergy to the study medication are excluded and would not be candidates for benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lower rates of delayed graft function, reduce ischemic injury, and improve early graft survival after deceased-donor kidney transplantation.
How similar studies have performed: Antioxidant and preservation-enhancement strategies have shown promise in preclinical models and limited clinical settings, but adding sodium thiosulfate directly to organ preservation solution for kidney transplants is relatively novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Alp Sener — Principal Investigator
- Study coordinator: Cadence Baker
- Email: cadence.baker@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Transplant, Kidney Transplant, Thiosulfate, Transplant, Renal, Kidney