Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01114529 | Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients | PHASE3 | COMPLETED | 828 | — | — | Aug 9, 2010 | Oct 30, 2014 | May 30, 2017 | 77 | Argentina, Australia +19 |
Assessment of renal function by comparing change from randomization to Month 12 in eGFR (MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR \[mL/min/1.73m˄2\] = 186.3\*(C˄-1.154)\*(A˄-0.203)\*G\*R. DEFINITIONS: C = serum concentration of creatinine \[mg/dL\]; A = age \[years\]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1
| Arm | Type | Description |
|---|---|---|
| Everolimus | EXPERIMENTAL | Conversion from CNI to everolimus in combination with Myfortic and steroids |
| Calcineurin inhibitor, Prograf or Neoral | ACTIVE_COMPARATOR | Control arm: CNI continuation, either Prograf or Neoral in combination with Myfortic and steroids |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Early CNI to everolimus conversion |
| Prograf or Neoral | DRUG | Active CNI-based control (Prograf or Neoral) |
Inclusion Criteria at Baseline: * Male or female renal allograft recipients at least 18 years old. * Written informed consent. * Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor. * Cold ischemia time (CIT) \< 24 hours. * Negative pregnan...