Prophylaxis of Renal Allograft Rejection
Conditions
Brief summary
The mean estimated glomerular filtration rate (eGFR) at 12 months.
Detailed description
The rate of graft functional impairment at 12 months. A participant is considered to have graft functional impairment if they either: A) Have an eGFR <60 mL/min/1.73m2 or B) Have a decrease in eGFR ≥ 10 mL/min/1.73m2 from Month 1 to Month 12;, The rate of NODAT at 12 months post-transplant;, The rate of patient and graft survival at 12 months post-transplant. Patient and graft survival are defined as either A) Death, B) Re-transplantation or C) Requirement for regular dialysis;, Rate of BPAR-free patient and graft survival at 12 months post-transplant;, Rate of BPAR at 12 months.
Interventions
DRUGMyfortic 360 mg gastro-resistant tablets
DRUGMyfortic 180 mg gastro-resistant tablets
DRUGAT-1501 475 mg Vial
DRUGThymoglobuline 25mg Powder for Solution for Infusion
Sponsors
Eledon Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean estimated glomerular filtration rate (eGFR) at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of graft functional impairment at 12 months. A participant is considered to have graft functional impairment if they either: A) Have an eGFR <60 mL/min/1.73m2 or B) Have a decrease in eGFR ≥ 10 mL/min/1.73m2 from Month 1 to Month 12;, The rate of NODAT at 12 months post-transplant;, The rate of patient and graft survival at 12 months post-transplant. Patient and graft survival are defined as either A) Death, B) Re-transplantation or C) Requirement for regular dialysis;, Rate of BPAR-free patient and graft survival at 12 months post-transplant;, Rate of BPAR at 12 months. | — |
Countries
France, Germany, Spain
Outcome results
None listed