Recruiting

STS

Sponsor:

Alp Sener

Code:

NCT06288152

Conditions

Renal Transplant

Kidney Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Thiosulfate

Study Details

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.

Conditions

Renal Transplant

Kidney Transplant

Study ID

NCT06288152

Start date

May 3, 2025

Status verified date

Apr, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Group

STS plus standard of care

no intervention: Control Group

Standard of care

Interventions

Sodium Thiosulfate

0.15 mL administered

Primary outcome measure

  • Effects of STS will be measured by: Delayed graft function [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Principal Investigator:

Alp Sener

More Information

Sponsor

Alp Sener

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Thiosulfate
  • Transplant
  • Renal
  • Kidney

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alp Sener on 2026-04-13.