NCT06288152 Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation
| NCT ID | NCT06288152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alp Sener |
| Condition | Renal Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-03 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-05-03 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation. This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function.
Eligibility 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.
Contact & Investigator
Alp Sener
PRINCIPAL INVESTIGATOR
Principal Investigator
Frequently Asked Questions
Who can join the NCT06288152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06288152 currently recruiting?
Yes, NCT06288152 is actively recruiting participants. Contact the research team at cadence.baker@lhsc.on.ca for enrollment information.
Where is the NCT06288152 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06288152 clinical trial?
NCT06288152 is sponsored by Alp Sener. The principal investigator is Alp Sener at Principal Investigator. The trial plans to enroll 120 participants.