A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients with Antibody-Mediated Rejection after Kidney Transplantation

Condition studied

Antibody-Mediated Rejection after Kidney Transplantation

Investigational medicinal product(s)

Eligibility

Primary endpoint

Biopsy-proven histologic resolution at Week 52

Endpoint detail

Biopsy-proven histologic resolution at Week 28., Resolution of AMR activity at Weeks 28 and 52., Change from baseline in biopsy-proven histologic score at Weeks 28 and 52., eGFR change from baseline at Week 52., Annualized total eGFR slope during 52 weeks of treatment., Stabilized eGFR (annualized eGFR slope > -1) during 52 weeks of treatment., Incidence of TEAEs and TESAEs over time., ALXN2030 plasma concentration over time., Absolute values, change from Baseline and percent change from Baseline in plasma concentrations of C3 protein over time and in serum complement functional activity over time., Anti-ALXN2030 Ab incidence, category of ADA response, and titer through the duration of the study.