Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

NCT06288152 | Recruiting

• 1 other identifier: STS-Transplant
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Thiosulfate; Transplant; Renal; Kidney

Outcome Measures

Primary Outcomes (1)

• Effects of STS will be measured by: Delayed graft function

  Number of participants requiring dialysis use post-transplant

  1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

STS plus standard of care

Drug: Sodium Thiosulfate

Control Group

NO INTERVENTION

Standard of care

Interventions

Sodium Thiosulfate DRUG

0.15 mL administered

Also known as: Seacalphyx

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alp Sener: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Interventions

sodium thiosulfate

Study Officials

• Alp Sener

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cadence Baker

CONTACT

519-685-8500; cadence.baker@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Alp Sener MD PhD FRCSC Lavergne Chair and Professor of Urology City-wide Head of Urology

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: March 1, 2024
• Study Start: May 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After study completion
• Access Criteria: To be determined

Locations

CA (1)