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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00195273 | Study Evaluating Sirolimus in Kidney Transplant Recipients | PHASE3 | COMPLETED | 61 | — | — | Nov 1, 2004 | Jul 1, 2008 | Apr 28, 2010 | 3 | Norway, Sweden |
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sirolimus + Daclizumab + Mycophenolate + Corticosteroids |
| 2 | ACTIVE_COMPARATOR | Cyclosporine + Mycophenolate + Corticosteroids |
| Name | Type | Description |
|---|---|---|
| sirolimus | DRUG | 15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12 |
| cyclosporine | DRUG | Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12 |
| mycophenolate mofetil | DRUG | 1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events |
| corticosteroids | DRUG | As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day |
| daclizumab | DRUG | IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation |
Inclusion Criteria: * Kidney transplantation * Donor must be at least 60 years old. Exclusion Criteria: * Current systemic infection * Unstable angina or treatment for serious arrhythmia. * Cancer within the previous 5 years.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 11 | PHASE3 | INCA034176, Tacrolimus, Methotrexate, Ruxolitinib, Cyclophosphamide |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |