Comparing High and Low Steroid Doses for Treating Acute T Cell Rejection in Kidney and Kidney-Pancreas Transplant Patients

What this Trial Is About

Researchers are studying acute T cell mediated rejection TCMR, a problem where the body tries to reject a new kidney or simultaneous kidney-pancreas transplant. This rejection can cause serious issues or lead to transplant failure. The study aims to find the safest and most effective steroid dose to treat this condition, addressing a long-standing question in transplant care. The trial is a phase 3, international, multi-center, randomized controlled study involving transplant recipients who have biopsy-proven acute TCMR. The trial compares high versus low doses of intravenous methylprednisolone IV MP and oral prednisone taper as first-line treatments. Four treatment groups receive different combinations of high or low doses of IV MP for three days followed by high or low doses of oral prednisone for seven days, then return to standard prednisone dosing. The study is triple-blind and factorial in design, supported by major international transplant societies, and led by a multidisciplinary team. Participants will be involved for at least 12 weeks post-randomization, during which researchers will assess resolution of biopsy-proven acute rejection, improvement in transplant function, and avoidance of additional rescue therapies. Secondary assessments include kidney function, survival of the transplant, infection rates, quality of life, and development of chronic rejection or fibrosis up to 48 weeks. Safety and effectiveness will be closely monitored throughout the study period.

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