Prophylaxis of Renal Allograft Rejection
Conditions
Brief summary
Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs)., Changes in vital signs and clinical laboratory measures., Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Detailed description
Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis, The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2, The mean eGFR at 12, 24, 36, and 48 months, Proportion of participants with BPAR at 12, 24, 36, and 48 months, Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs)., Changes in vital signs and clinical laboratory measures., Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis, The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2, The mean eGFR at 12, 24, 36, and 48 months, Proportion of participants with BPAR at 12, 24, 36, and 48 months, Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months | — |
Countries
France, Germany, Spain