TACKLE-IT - A multicenter randomized controlled trial to Treat ACute T cell mediated rejection in Kidney and kidney pancreas transpLant rEcIpienTs
Transplant is the first choice for most people living with kidney failure, as it improves survival and quality of life compared to dialysis. Improving how long a transplanted kidney lasts is a major priority for patients around the world. One important reason why a kidney transplant fails sooner than expected is T-cell mediated rejection (TCMR).
In TCMR, the patient’s immune system attacks and damages the transplant kidney and can lead to its loss.
The most common therapy for TCMR is “high-dose steroids,” but the international community does not know or agree on the correct dose due to a lack of data, so different centers use different doses, which can result in too much or too little steroids.
Too much steroids can cause serious side effects, such as an increased risk of infections, diabetes, high blood pressure, high cholesterol and bone complications, as well as limiting growth in kids with a kidney transplant.
Too little steroids can fail to stop rejection.
Our research has shown that 39-50% of patients treated with high dose steroids do not get remission which can lead to an increased risk of transplant loss and death.
Our goal is to improve overall TCMR care to lengthen transplant and patient survival.
This project will perform an international, multicenter, randomized controlled trial to define the standard-of-care therapy for TCMR and resolve a decades-long unanswered question, ‘What is the minimally acceptable, safe and effective steroid dose for the treatment of acute TCMR in kidney and simultaneous kidney pancreas transplant recipients?’
This data will inform clinical practice around the world and be used to help design the next stage of trials to test new drugs for TCMR. Ultimately our goal is to find the optimal dose of steroids that achieves TCMR remission while minimizing their side effects, to improve patient and transplant survival in children and adults living with kidney failure.