RecruitingPHASE3INTERVENTIONAL

TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients

The TACKLE-IT study is for people who have received a kidney or kidney-pancreas transplant. Sometimes, after a transplant, the body mistakenly tries to get rid of the new organ; this is called 'rejection.' Doctors often use strong medicines called steroids to treat one type of rejection. However, there isn't a clear rule for how much steroid to give, and too much can lead to unwanted side effects like heart problems, infections, or weight gain. This study aims to find the safest and most effective dose of steroids to treat rejection, helping to protect patients' health while ensuring their new organ keeps working well. It's a key step in improving care for transplant patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Sydney

Enrolment target

540

Start

13 Mar 2026

Estimated completion

01 Jun 2030

Rejection; Transplant, Kidney Rejection; Transplant, Pancreas

What is this study about?

When someone receives a new kidney or a kidney and pancreas, it's a life-changing event. However, sometimes the body's immune system, which usually fights off germs, can mistakenly see the new organ as a foreign invader and try to attack it. This common problem is called 'rejection.' One particular type of rejection is called Acute T cell mediated rejection (TCMR), and if not treated properly, it can harm the new organ and stop it from working as it should.

Doctors often treat rejection with powerful medicines called steroids. These steroids help calm down the immune system to stop it from attacking the new organ. The challenge is, there isn't a clear guide on the exact dose of steroids to give. Giving too much can cause a range of serious side effects, such as heart issues, weakened bones, a higher risk of infections, and weight gain. On the other hand, not giving enough might mean the rejection isn't properly treated.

That's where the TACKLE-IT study comes in. Its main goal is to figure out the best dose of steroids – one that is strong enough to treat the rejection effectively but also gentle enough to avoid unnecessary side effects. This research is incredibly important because it will help doctors confidently choose the right treatment for each patient, improving their long-term health and the success of their transplant. The study team has worked closely with patients and transplant experts from around the world to design this research, making sure it addresses the real-world needs of transplant recipients.

Key takeaways

The study aims to improve treatment for kidney and kidney-pancreas transplant rejection.
It seeks the safest and most effective steroid dose to treat rejection.
Participation could help future transplant patients.
Patients will be closely monitored throughout the study.
It includes children aged 2 and above, as well as adults.
Joining is voluntary, and you can leave at any time.

Who may be eligible?

This study is looking for both children (aged 2 and older) and adults who have received a kidney transplant, or both a kidney and pancreas transplant. To be considered, doctors need to have confirmed that you are experiencing a specific type of rejection called 'acute T cell mediated rejection,' often discovered through a biopsy (taking a small sample of the organ).

There are some reasons why someone might not be able to join. For example, if you have other types of rejection happening at the same time, or if you have certain other serious health conditions like active cancer or serious infections that would make it risky to adjust your medication. Also, if you are already taking part in another drug study or are unable to follow the study's plan, you likely won't be able to join this one.

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.

Have you had a kidney transplant, or both a kidney and pancreas transplant?
Has a doctor confirmed you have 'acute T cell mediated rejection'?
Are you able to understand and agree to the study procedures?
Are you not currently part of another drug trial?
Do you not have certain other serious health problems like active cancer or severe infections?

Answer every question to see your result.

What does participation involve?

Taking part in the study would involve closely following a treatment plan for your rejection, which includes receiving specific doses of steroids. These will be given either through a drip into your arm (intravenous) or as pills (oral), based on which group you are in. You would have regular appointments with your healthcare team to check how you're doing, monitor your health, and ensure the new organ is working well. This includes blood tests, urine tests, and potentially more biopsies if needed, to see how the rejection is responding. The doctors coordinating the study will carefully track your progress over time to see the effects of the different steroid doses. The exact number of visits and the full duration of your participation would be discussed in detail by the study team.

Potential risks and benefits

By taking part, you could potentially benefit from receiving a more tailored and effective steroid dose for your rejection, which might lead to fewer side effects in the long run and better health for your transplanted organ. There's also the benefit of helping other transplant patients in the future by improving our understanding of the best treatments. However, like all medical treatments, there are potential risks, including the side effects of steroids or the possibility that the dose you receive might not be as effective as expected. Your condition will be closely monitored by medical professionals throughout the study. Remember, joining is completely voluntary, and you are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (25)

John Hunter Hospital
Verified postcode
Lambton, Australia· Not yet recruiting
Prince of Wales Hospital
Verified postcode
Randwick, Australia· Not yet recruiting
The Sydney Children's Hospital Network
Verified postcode
Westmead, Australia· Not yet recruiting
Westmead Hospital
Verified postcode
Westmead, Australia· Recruiting
Queensland Children's Hospital
Verified postcode
South Brisbane, Australia· Recruiting
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia· Not yet recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Not yet recruiting
Monash Medical Centre
Verified postcode
Clayton, Australia· Not yet recruiting
Royal Perth Children's hospital
Verified postcode
Nedlands, Australia· Not yet recruiting
Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia· Not yet recruiting
Royal Perth Hospital
Verified postcode
Perth, Australia· Not yet recruiting
University of Calgary
Verified postcode
Calgary, Canada· Not yet recruiting

Common questions

What is 'rejection' in a transplant?

Rejection is when your body's immune system mistakenly tries to attack and get rid of your new transplanted organ, like a kidney or pancreas.

Why is this study needed?

Doctors want to find the best dose of steroids to treat rejection – enough to work, but not so much that it causes lots of unwanted side effects.

What kind of organs are involved in this study?

This study is for people who have received a new kidney, or both a new kidney and a new pancreas.

Will I know if I'm getting a high or low dose of medicine?

No, neither you nor your doctors will know which dose you're receiving during the study. This helps ensure fair and accurate results.

Can children join this study?

Yes, children aged 2 years and older who meet the study requirements can participate.

How to find out more

NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY

tackle-it.study@sydney.edu.au +61 2 9562 5000 Official trial record

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