Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

Sponsor
Alp Sener
Study ID
NCT06288152
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Transplant
  • Renal Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sodium Thiosulfate — DRUG
    0.15 mL administered

Study Details

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.

Key Dates

First listed
Mar 1, 2024
Start date
May 3, 2025
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Group
    STS plus standard of care
  • No Intervention: Control Group
    Standard of care

Primary Outcome Measure

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

Central Contacts

Related Studies