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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00167947 | Study Evaluating Sirolimus in Kidney Transplant Recipients. | PHASE3 | COMPLETED | 150 | — | — | Jan 1, 2005 | Jul 1, 2007 | Mar 14, 2008 | 14 | Italy |
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cyclosporine | DRUG | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
| Steroids | DRUG | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
| Rapamune (Sirolimus) | DRUG | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
Inclusion Criteria: * Age is older than 18 years. * End-stage renal disease, with subjects scheduled for kidney transplant. * Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following dis...