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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01544491 | Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients | PHASE3 | COMPLETED | 106 | — | — | Aug 17, 2012 | Sep 24, 2018 | May 31, 2019 | 31 | United States, Argentina +11 |
To estimate the rate of the composite efficacy endpoint of biopsy-proven acute rejection (BPAR), graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids.
To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (abbreviated) (Schwartz, 2009).
| Arm | Type | Description |
|---|---|---|
| Investigational arm | EXPERIMENTAL | Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant |
| Control arm | ACTIVE_COMPARATOR | MMF continuation (in combination with tacrolimus and standard dose steroids) |
| Name | Type | Description |
|---|---|---|
| RAD001 | DRUG | Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant |
| MMF | DRUG | MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids |
Inclusion Criteria: Inclusion criteria at baseline: 1. Written informed consent/assent must be obtained from the parent(s) or legal guardian before any assessment is performed. 2. Primary or secondary paediatric kidney transplant recipient aged greater than or equal to 1 year and younger than 18 y...