Treatment of Late Isolated Microvascular Inflammation in Recipients of Kidney Transplants
Conditions
Brief summary
Percentage of participants who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria)
Detailed description
Part A : • MVI score at Week 24 (Month 6) (Banff 2022 criteria) • Percentage of participants who achieve MVI score of 0 at Week 24 (Banff 2022 criteria) • Change in eGFR from Baseline to Week 24 • Percentage of participants in the C4d-positive cohort who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria), Part B Arm 1:• Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve the MVI score of 0 (Banff 2022 criteria) • Change in estimated glomerular filtration rate (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 MVI score of 0 (Banff 2022 criteria) • Change in eGFR from Week 24 • Time to all-cause allograft loss, Parts A and B: • Incidence and severity of adverse events (AEs) [treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)] • Percentage of participants with TCMR on biopsy at Week 24 and at Week 52 (Banff 2022 criteria) • Laboratory assessments, vital sign measurements, and ECG
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A : • MVI score at Week 24 (Month 6) (Banff 2022 criteria) • Percentage of participants who achieve MVI score of 0 at Week 24 (Banff 2022 criteria) • Change in eGFR from Baseline to Week 24 • Percentage of participants in the C4d-positive cohort who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria), Part B Arm 1:• Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve the MVI score of 0 (Banff 2022 criteria) • Change in estimated glomerular filtration rate (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 MVI score of 0 (Banff 2022 criteria) • Change in eGFR from Week 24 • Time to all-cause allograft loss, Parts A and B: • Incidence and severity of adverse events (AEs) [treatment-emergent adverse events (TEAEs), serious adverse e | — |