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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00267189 | RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency | PHASE3 | COMPLETED | 145 | — | — | Nov 1, 2005 | Nov 1, 2007 | Apr 13, 2011 | 2 | Germany, Switzerland |
The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits. CrCl\[mL/min\] = (140 - A) \* W / (72 \* C) \* R. Where A is age at sample date \[years\], W is body weight at specific visit \[kg\], C is the serum concentration of creatinine \[mg/dL\], R = 1 if the patient is male and = 0.85 if female.
| Arm | Type | Description |
|---|---|---|
| Reduced CNI dose + everolimus ± steroids | ACTIVE_COMPARATOR | Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids |
| CNI continuation ± MPA/AZA ± Steroids | EXPERIMENTAL | Standard CNI dose ± MPA/AZA ± steroids |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | 1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation |
| Calcineurin inhibitors (CNI) | DRUG | - |
| Mycophenolate acid (MPA)/ Azathioprine (AZA) | DRUG | - |
| Steroids | DRUG | - |
Inclusion criteria * Male or female 18 - 70 years old * Patient who has undergone a primary liver transplantation 12 to 60 months ago from a cadaveric or a living donor * Patient with a calculated GFR ≤ 60 and ≥ 20mL/min * Patient receiving tacrolimus with C0-h level ≥ 3 and ≤ 8 ng/mL or Neoral® wi...