TACKLE-IT is an international multi-centre single-blind randomised controlled trial (RCT) employing a 2×2 factorial approach and utilising registry data. The main aim is to assess the efficacy and safety of high versus low doses of IV MP (Methyl prednisone), and high versus low doses of oral prednisone taper as the primary treatment for acute TCMR in recipients of kidney and SPK transplants. Population will consist of children (aged 2+ years) and all adults who have received a kidney or kidney pancreas transplant with biopsy proven acute TCMR. The recruitment period will span for 4 years.

TACKLE-IT is led by an international multi-disciplinary team of transplant health professionals, clinical trialists, biostatisticians, health economist, social scientist, and consumers. This collective effort endeavours to address a longstanding unanswered query: “What constitutes the minimally acceptable, safe, and efficacious steroid dose for treating acute TCMR in kidney and SPK transplant recipients?” 

TACKLE-IT represents a pivotal step forward in meeting the critical unmet needs within this field, offering promise to resolve a longstanding question that has persisted for decades.