The TACKLE IT Trial
A multi-centre randomized controlled trial to Treat ACute T cell mediated rejection in Kidney and SPK transpLant rEcIpienTs.
What is TACKLE IT?
The kidney and pancreas are important organs in our body. The kidney helps clear waste and make urine, while the pancreas helps with digestion. The pancreas also produces insulin to help control the sugar levels in your body. If the pancreas is not working well, it can cause diabetes. If the kidneys stop working, people will need to receive dialysis (a treatment that helps remove waste and extra water from your body) or receive a kidney transplant.
Sometimes, people may receive a kidney and a pancreas transplant at the same time if both organs are not working well. We call this a simultaneous kidney-pancreas transplant, or SPK.
TACKLE IT is a study of patients who have had a kidney or SPK transplant.
Why do we need TACKLE IT?
After a kidney or SPK transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called “rejection”. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.
Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That’s why we need to find the right dose of steroids for each person to treat this.
TACKLE IT is a study that will try to find the right steroid dose for treating rejection.
Who can join the study?
Children (who are aged more than 2 years) and adults who have received a kidney or SPK transplants and have been told that they have TCMR rejection.
How many people will be in the trial?
We plan to have a total of 540 people from Australia, Canada, and New Zealand for 3 years. The study will start at the end of 2024.
