AuthorisedPhase II and Phase III (Integrated)Interventional

Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study

The TRAINING Study is a research project for people with kidney transplants who are at low risk of their body rejecting the new kidney. The main goal is to see if treating early, minor problems (called 'borderline lesions') that appear around three months after a transplant can help the kidney last longer and work better. Researchers are comparing a special anti-rejection medicine called Grafalon to the usual care. They want to know if this treatment can prevent or slow down damage to the kidney (fibrosis and tubular atrophy) and keep its function strong for at least two years after the transplant. The study also investigates how this treatment might affect certain body chemicals and overall health.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Fundacion Canaria Instituto De Investigacion Sanitaria De Canarias

Enrolment target

Start

29 Jan 2025

To analyze whether the anti-rejection treatment of borderline lesions can modify the expression and klotho levels as well as proinflammatory cytokines that regulate klotho expression at both years post-transplant.Know in a controlled and randomized clinical trial carried out in low-risk patients immunological and stable renal function if the treatment of BL lesions detected in the third month post-transplant with rabbit polyclonal antilymphocytic globulin prevents or slows the progression of chronic histological lesions of the graft (FIAT) and the deterioration of its function compared to clinical follow-up conventional after two years of post-transplant follow-up.

What is this study about?

When you have a kidney transplant, doctors keep a close eye on the new kidney to make sure it's working well and that your body doesn't try to reject it. Sometimes, around three months after the transplant, a kidney biopsy might show very early, minor changes that doctors call 'borderline lesions.' These aren't full rejection, but they could potentially lead to problems later on.

'The TRAINING Study' is designed to investigate these borderline lesions. We want to find out if giving a specific anti-rejection treatment, called Grafalon, when these early changes are found, can help prevent bigger problems down the line. We're comparing this special treatment to the standard approach, which usually involves close monitoring without extra medication at this early stage. The study focuses on people who have a low risk of their body rejecting the kidney and whose kidney is working well.

The main aim is to see if treating these borderline lesions can stop or slow down scarring and damage inside the kidney, and ultimately keep the new kidney working better for longer. We'll be looking at the kidney's function over at least two years after the transplant. The study will also explore how the treatment affects chemicals in the body and other important health measures, like blood pressure, cholesterol, and the risk of developing diabetes.

Key takeaways

The study explores treating early kidney transplant issues (borderline lesions).
It compares a special medicine (Grafalon) to standard care.
Aims to improve long-term kidney function and prevent damage.
Focuses on low-risk kidney transplant patients.
Involves regular check-ups and monitoring over two years.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) and have had a kidney transplant. The study is open to everyone, regardless of whether you are male or female.

Doctors will also check other things to make sure the study is right for you. They'll confirm that you are considered to be at low risk of your body rejecting your new kidney and that your kidney is working well and stable. You would also need to have shown these early minor changes, called 'borderline lesions', in a kidney biopsy around three months after your transplant.

Quick self-check

I am 18 years old or older.
I have received a kidney transplant.
My doctors consider me to be at low risk for kidney rejection.
My kidney function is currently stable.
I would need to have had 'borderline lesions' found in a biopsy around 3 months post-transplant.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be assigned to one of two groups: either you would receive the special Grafalon treatment, or you would continue with your usual medical care and monitoring. The Grafalon treatment involves infusions (medicine given through a drip) and would be closely supervised by doctors.

Over two years, you would have several follow-up visits. These visits would include check-ups, blood tests to measure kidney function and other health markers, and possibly further kidney biopsies. Doctors would look at things like your blood pressure, cholesterol levels, and check for signs of diabetes. You would also be asked about how well you are taking your other regular medicines. The full study duration for you would be two years.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of better long-term kidney function if the Grafalon treatment proves effective for early borderline lesions. However, all medical treatments carry some risks, and Grafalon, like any medicine, can have side effects which your doctor would discuss with you. There's also the possibility that the treatment might not be more effective than standard care. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What are 'borderline lesions'?

These are very early, minor changes seen in a kidney biopsy after a transplant. They're not full rejection but could sometimes lead to problems if left unmanaged.

What is Grafalon?

Grafalon is a specific medicine given to help prevent your body from rejecting the new kidney. In this study, we're seeing if it helps with these early borderline lesions.

How long will the study last if I join?

Your participation in the study would involve monitoring and follow-up for two years after your kidney transplant.

Will I still take my regular kidney medicines?

Yes, you would continue your usual kidney transplant medications. The study is looking at adding an intervention, not replacing your standard care.

What if I change my mind about participating?

You are free to stop participating in the study at any time, for any reason, without affecting your medical care.