Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
standard therapy · 1 trial · 1 indication
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 | N/A | Undisclosed |
Standard therapy is an investigational small molecule being studied for use in lung transplantation. It is being evaluated in a Phase 3 clinical trial in combination with everolimus and a specific immunosuppressive regimen to assess its effects on renal function in lung transplant recipients. The drug is not yet approved and remains in clinical development.
Standard therapy is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this drug for lung transplantation. As of the available data, the drug is in Phase 3 development and has completed one clinical trial.
Standard therapy is in Phase 3 clinical development for lung transplantation. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is still being evaluated for safety and efficacy in this patient population.
Standard therapy has been studied in one completed Phase 3 clinical trial, identified as NCT01404325. This trial enrolled 130 participants and was conducted in Germany. The study evaluated the efficacy of everolimus in combination with a specific standard immunosuppressive regimen in lung transplant recipients, focusing on renal function outcomes.
Standard therapy is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for lung transplantation. The available data shows that one Phase 3 trial has been completed, but approval status has not been established. The drug remains under investigation for this indication.