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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01404325 | Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients | PHASE3 | COMPLETED | 130 | — | — | Feb 1, 2012 | Jan 5, 2017 | Mar 14, 2019 | 9 | Germany |
Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)\^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1
| Arm | Type | Description |
|---|---|---|
| Quadruple low level IS regimen | EXPERIMENTAL | quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids |
| Centre specific triple IS regimen | EXPERIMENTAL | centre specific CNI-based triple drug immunosuppression (IS) |
| Name | Type | Description |
|---|---|---|
| standard therapy | DRUG | centre specific CNI-based triple drug immunosuppression |
| Everolimus | DRUG | quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids |
Inclusion criteria: * Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment Exclusion criteria: * Patients with thrombocytopenia (platelets \<100,000/mm³), with an absolute neutrophil count of \<1,500/mm³ or leucopenia (leucocytes \<3000/mm³), with anemia with Hb ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| TransMedics Group, Inc. | TMDX | 4 | — | Undisclosed |
| CareDx, Inc. | CDNA | 1 | NA | Undisclosed |