A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection (AMR) (TRANSCEND / 299AR301)

Kidney Transplant Recipients with Late Antibody-Mediated Rejection

Percentage of participants who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria)

Part A: • MVI score at Week 24 (Month 6) (Banff 2022 criteria) • Percentage of participants who achieve an MVI score of 0 at Week 24 (Banff 2022 criteria) • Change in dd-cfDNA from Baseline to Week 24 • Change in biopsy-based transcript composite score for AMR/MVI from Baseline to Week 24 • Change in eGFR from Baseline to Week 24, Part B Arm 1: • Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve an MVI score of 0 (Banff 2022 criteria) • Change in dd-cfDNA from Baseline • Change in biopsy-based transcript composite score for AMR/MVI from Baseline • Change in eGFR from Baseline • Time to all-cause allograft loss, Part B Arm 2: • Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve an MVI score of 0 (Banff 2022 criteria) • Change in dd-cfDNA from Week 24 • Change in biopsy-based transcript composite score for AMR/MVI from Week 24 • Change in eGFR from Week 24 • Time to all-cause allograft loss, Parts A and B: • Incidence and severity of AEs (TEAEs, SAEs, and AESIs) • Percentage of participants with TCMR on biopsy at Week 24 and Week 52 (Banff 2022 criteria) • Laboratory assessments, vital sign measurements, and ECG, Parts A and B: • Felzartamab serum concentrations over time • Baseline prevalence and post-Baseline incidence of ADAs against felzartamab in serum over time

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