RecruitingNAINTERVENTIONAL

Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

This study is looking at how to make kidney transplants more successful, especially when using kidneys from deceased donors. These kidneys can be a bit more fragile because of how they're stored and transported. We're testing a special solution that contains a medicine called sodium thiosulfate. When a kidney is removed from a donor, it's usually kept in a cool solution. In this study, we'll add sodium thiosulfate to this solution for some kidneys. We believe this addition could help protect the kidney from damage that can happen before the transplant, similar to how it helped in earlier animal studies. The goal is to improve how well the new kidney works after transplantation and help it last longer for the person receiving it.

At a glance

Status

Recruiting

Phase

Sponsor

Alp Sener

Enrolment target

120

Start

03 May 2025

Estimated completion

01 Mar 2027

Renal Transplant Kidney Transplant

What is this study about?

When someone's kidneys stop working properly, they often need a kidney transplant, which is the best treatment option. Unfortunately, there aren't enough donated kidneys for everyone who needs one. This means doctors often need to use kidneys from deceased donors, which are sometimes not as strong as kidneys from living donors.

Kidneys from deceased donors can get damaged more easily before they are transplanted. This damage can happen because they're without a blood supply for a while, and also during the time they are kept cold in a special solution before the operation. This can sometimes lead to the new kidney taking a bit longer to start working properly after the transplant.

Our research team has been looking for ways to protect these kidneys better. We've found that adding a specific substance, called sodium thiosulfate, to the solution used to store the kidney might help. We've seen positive results in animal studies, where kidneys treated with this substance stayed healthier and worked better. Now, we want to see if this method can also help people receiving kidney transplants.

Key takeaways

This study tries to make kidney transplants from deceased donors more successful.
A special solution with sodium thiosulfate is being tested to protect the donated kidney.
The treatment happens to the kidney before it is transplanted into you.
You won't know if your kidney received the special solution.
Your health will be followed for one year after the transplant.
The aim is for transplanted kidneys to work better and last longer.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older, who has severe kidney disease and is going to receive a kidney transplant. The kidney you receive must be from a deceased donor, not a living donor.

There are some reasons why you wouldn't be able to join. For example, if you are under 18, or if you can't give your informed consent (meaning you can't fully understand and agree to take part). Also, if you are pregnant, have a known allergy to the study medication or its components, or if you're having a multi-organ transplant (like a kidney and pancreas together), this study wouldn't be right for you.

Finally, if you're already in another transplant-related or similar clinical trial that might affect the results of this study, you wouldn't be able to participate here.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe kidney disease and need a kidney transplant?
Will your donated kidney come from a deceased donor?
Are you able to understand and agree to participate in a study?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference for you will happen when the donated kidney is being prepared for your transplant surgery. After the kidney is removed from the donor, it's placed on a special pump that keeps it cool. If you are in the group receiving the special solution, a small amount of sodium thiosulfate will be added to this pump solution.

After your kidney transplant, we will follow your health for one year. During this time, you'll have regular blood and urine tests, which are standard for anyone who has had a kidney transplant. These tests will help us understand how well your new kidney is working. The study won't involve any extra visits beyond your usual transplant follow-up appointments, but we will be collecting information from those appointments.

Potential risks and benefits

The potential benefit of participating is that the special solution might help your new kidney work better and last longer, potentially reducing complications right after the transplant. However, it's important to know that this is a research study, and we can't guarantee any specific benefits for you personally. The risks involved are minimal, as sodium thiosulfate is a known substance and will be used externally on the donated organ, not directly injected into you. As with any clinical trial, you are free to withdraw from the study at any time, for any reason, without it affecting the care you receive.

Locations (1)

London Health Sciences Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is sodium thiosulfate?

It's a medicine that we think can help protect donated kidneys from damage before they are transplanted.

Will I know if my kidney is treated with the special solution?

No, this is a 'single-blind' study, meaning you won't know if your donated kidney received the added solution or not.

How long will I be followed in the study?

We will follow your health and conduct tests for one year after your kidney transplant.

Are there any side effects for me?

The solution is used to treat the donor kidney before transplant, so direct side effects for you are not expected.

What kind of kidney is used in this study?

Only kidneys from deceased donors will be used in this study.

How to find out more

Cadence Baker

cadence.baker@lhsc.on.ca 519-685-8500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.