Table 3 Unique features of the IMAGINE study
The design of the IMAGINE study has a number of unique features: • The study includes prognostic biomarker enrichment—Banff (cg) >0 with HLA DSA. • The study uniquely incorporates a reasonably likely surrogate endpoint for all-cause graft loss: eGFR slope at 1 year, which may accelerate the approval of a novel therapy for patients at risk of graft loss. Identifying an early surrogate endpoint is a major challenge and this represents a first in kidney transplantation [40] • IMAGINE is the only Phase 3 trial underway in chronic active AMR after kidney transplantation. • Crucially, the study follows patients through to the clinical endpoint of all-cause graft loss to fully evaluate the clinical potential of clazakizumab. • Sample size re-estimation when approximately 100 patients have completed 1 year of follow-up will ensure the surrogate endpoint trial is appropriately powered. • IMAGINE has been accepted by the FDA as a single study for approval, which is unusual for the transplant therapy area. • The uniqueness of the SC route and Q4W administration opens the possibility for delivering home care for these patients, removing the need for infusion centers for this therapeutic intervention. • Treatment with clazakizumab is a sustained regime, akin to treatments for autoimmune diseases, rather than the typical short course nature of current AMR and TCMR regimes. |