Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation
Launched by ALP SENER · Feb 23, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to improve the preservation of kidneys from deceased donors before they are transplanted into patients. Currently, kidneys from deceased donors can suffer damage due to the lack of blood supply after the donor's heart has stopped beating, which can affect their function after transplantation. The researchers are testing a substance called sodium thiosulfate (STS), which may help protect the kidneys and improve their performance once transplanted. By adding STS to the preservation solution used for these kidneys, the hope is to enhance their viability and ultimately improve outcomes for transplant recipients.
To participate in this study, individuals must be 18 years or older and have end-stage renal disease, meaning their kidneys are no longer working well enough on their own. They must also be receiving a kidney transplant from a deceased donor. Participants will be randomly assigned to receive either the STS treatment or standard care, and they will be monitored for one year after their transplant through blood and urine tests to assess how well their new kidney is functioning. This trial aims to gather more information on how effective STS is in improving kidney preservation and patient outcomes.
Gender
ALL
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.
About Alp Sener
Alp Sener is a distinguished clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodology and adherence to regulatory standards, Alp Sener collaborates with a network of leading healthcare professionals and research institutions. The organization is committed to conducting high-quality clinical trials across various therapeutic areas, ensuring patient safety and data integrity while striving to bring new treatments to market efficiently and effectively. Through its comprehensive approach and dedication to excellence, Alp Sener plays a vital role in the evolution of healthcare and the development of breakthrough therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Alp Sener
Principal Investigator
Principal Investigator
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported