Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

February 23, 2024 updated by: Alp Sener

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Full description pending

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Standard of care
Experimental: Intervention Group
STS plus standard of care
Drug: Sodium Thiosulfate
0.15 mL administered
Other Names:
  • Seacalphyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of STS will be measured by: Delayed graft function
Time Frame: 1 year
Number of participants requiring dialysis use post-transplant
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alp Sener

Investigators

  • Principal Investigator: Alp Sener, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STS-Transplant

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study report

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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