Lambton

Researchers are investigating the best steroid dose to treat acute T cell mediated rejection (TCMR) in patients who have received a kidney or simultaneous kidney-pancreas transplant. This condition occurs when the body mistakenly attacks the new organ, risking transplant failure. The study aims to determine a safe and effective steroid dose, addressing a long-standing question in transplant care. The trial compares high versus low doses of intravenous methylprednisolone and oral prednisone taper as first-line treatments for acute TCMR. It is an international, multi-center, triple-blind, randomized controlled trial involving kidney and simultaneous pancreas-kidney transplant recipients. The study includes two phases of steroid treatment delivered by IV and orally, testing different dose combinations to evaluate their safety and effectiveness. Participants will be monitored over 12 weeks post-randomization to assess biopsy-proven resolution of rejection, improvement in organ function, and avoidance of additional rescue therapies. Researchers will perform biopsies, function tests, and regular evaluations to track treatment response and safety. The study’s goal is to find the minimum steroid dose that effectively treats rejection while minimizing side effects, improving long-term transplant outcomes.