Transplant Rejection
Conditions
Brief summary
Cohort A: Treatment failure rate, Cohort B: AMR resolution rate
Detailed description
Cohort A: Treatment failure rate, Cohort B: AMR resolution rate, Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD), Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio, Change in allograft histopathology Banff score, Graft survival as predicted by iBOX, Assessment of adverse events (AEs), Change in systemic lupus erythematosus (SLE) panel, Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin, Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC, Number of participants with anti-BIVV020 antibodies
Interventions
DRUGriliprubart
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A: Treatment failure rate, Cohort B: AMR resolution rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A: Treatment failure rate, Cohort B: AMR resolution rate, Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD), Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio, Change in allograft histopathology Banff score, Graft survival as predicted by iBOX, Assessment of adverse events (AEs), Change in systemic lupus erythematosus (SLE) panel, Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin, Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC, Number of participants with anti-BIVV020 antibodies | — |
Countries
France, Germany, Italy, Spain, Sweden
Outcome results
None listed