A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Finding, Active-Controlled Study of Siplizumab (TCD601) Compared to Rabbit Anti-Thymocyte Globulin in Renal Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression with Tacrolimus, Mycophenolic Acid and Corticosteroids (MODERNIZE 1)

Condition studied

Renal Transplantation

Investigational medicinal product(s)

Every trial of Siplizumab across our registers →

Eligibility

Primary endpoint

Number and percentage of participants at 12 months post-transplant experiencing adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).

Endpoint detail

Composite incidence of BPAR, death, graft loss, and loss-to-follow-up., Incidence of participants who experienced BPAR as defined by central pathology (blinded independent central review using Banff Allograft Pathology Scoring)., Grade and severity of BPAR., Time to first BPAR for each participant., Incidence of treated BPAR and steroid-resistant BPAR., Participant survival at 12 months, Graft survival at 12 months., Time to graft loss for each participant., Time to death for each participant., Number of participants requiring for-cause renal allograft biopsy assessments over 12 months post-transplant., Siplizumab Cmax (maximum blood concentration) and AUC (area under the concentration-time curve) over 12 weeks post-transplant., Depletion and recovery of lymphocyte count by subset (total lymphocytes; CD3+, CD4+, and CD8+ T cells; CD19+ B cells; CD56+ NK cells) over 12 months post-transplant