Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

NCT ID: NCT06288152

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-03-01

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.

Detailed Description

Full description pending

Conditions

Renal Transplant; Kidney Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

STS plus standard of care

Group Type: EXPERIMENTAL

Sodium Thiosulfate

Intervention Type: DRUG

0.15 mL administered

Control Group

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sodium Thiosulfate

0.15 mL administered

Intervention Type: DRUG

Other Intervention Names

Seacalphyx

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alp Sener

OTHER

Sponsor Role: lead

Responsible Party

Alp Sener

Alp Sener MD PhD FRCSC Lavergne Chair and Professor of Urology City-wide Head of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alp Sener

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Central Contacts

Cadence Baker

Role: CONTACT

cadence.baker@lhsc.on.ca

519-685-8500 ext. 34769

Other Identifiers

STS-Transplant

Identifier Type: -

Identifier Source: org_study_id