Late antibody mediated rejection (AMR)
Conditions
Brief summary
1. Incidence of treatment-emergent adverse events (TEAEs) including those occurring in ≥5% of the safety population by Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT)., 2. Incidence of related TEAEs including those occurring in ≥5% of the safety population by MedDRA PT., 3. Incidence of serious adverse events., 4. Incidence of adverse events of special interest., 5. Incidence of adverse event (AE) leading to treatment discontinuation., 6. Incidence of clinically significant abnormal laboratory test results and vital signs.
Detailed description
01. Microvascular inflammation (MVI) score (the sum of glomerulitis and peritubular capillaritis scores, that is, g+ptc) in biopsy samples at Week 24. • Achievement of a MVI score of 0 at Week 24. • Change in MVI score from baseline at Week 24., 02. • Achievement of biopsy-proven histologic resolution of AMR activity at Week 48 (all arms) and Week 70 (Arm B only). • MVI score (the sum of glomerulitis and peritubular capillaritis scores, that is, g+ptc) in biopsy samples at Week 48 (all arms) and Week 70 (Arm B only). • Achievement of a MVI score of 0 at Week 48 (all arms) and Week 70 (Arm B only)., 02b. Change in MVI score from baseline at Week 48 (all arms) and Week 70 (Arm B only). • Change in eGFR from baseline at Week 48 and Week 70. • Change in dd-cfDNA from baseline at Week 48 and Week 70. • Change in UPCR from baseline at Week 48 and Week 70., 03. Percentage of participants with TCMR by biopsy at Week 24 and Week 48., 04. Percentage of Arm B participants with TCMR by biopsy at Week 70 (Arm B only)., 05. Serum concentration of mezagitamab during and after intervention., 06. • Incidence of anti-drug antibody. • Incidence of neutralizing antibody., 01 (continued) • Change in estimated glomerular filtration rate (eGFR) from baseline at Week 24. • Change in donor-derived cell-free DNA (dd-cfDNA) from baseline at Week 24. • Change in urine protein creatinine ratio (UPCR) from baseline at Week 24.
Interventions
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (TEAEs) including those occurring in ≥5% of the safety population by Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT)., 2. Incidence of related TEAEs including those occurring in ≥5% of the safety population by MedDRA PT., 3. Incidence of serious adverse events., 4. Incidence of adverse events of special interest., 5. Incidence of adverse event (AE) leading to treatment discontinuation., 6. Incidence of clinically significant abnormal laboratory test results and vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 01. Microvascular inflammation (MVI) score (the sum of glomerulitis and peritubular capillaritis scores, that is, g+ptc) in biopsy samples at Week 24. • Achievement of a MVI score of 0 at Week 24. • Change in MVI score from baseline at Week 24., 02. • Achievement of biopsy-proven histologic resolution of AMR activity at Week 48 (all arms) and Week 70 (Arm B only). • MVI score (the sum of glomerulitis and peritubular capillaritis scores, that is, g+ptc) in biopsy samples at Week 48 (all arms) and Week 70 (Arm B only). • Achievement of a MVI score of 0 at Week 48 (all arms) and Week 70 (Arm B only)., 02b. Change in MVI score from baseline at Week 48 (all arms) and Week 70 (Arm B only). • Change in eGFR from baseline at Week 48 and Week 70. • Change in dd-cfDNA from baseline at Week 48 and Week 70. • Change in UPCR from baseline at Week 48 and Week 70., 03. Percentage of participants with TCMR by biopsy at Week 24 and Week 48., 04. Percentage of Arm B participants with TCMR by biopsy at W | — |
Outcome results
None listed