Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Calcineurin inhibitors · 1 trial · 1 indication
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...
Calcineurin inhibitors are used for Liver Transplantation, specifically to manage patients who have undergone liver transplant surgery. The drug is being studied in the context of renal insufficiency in liver transplant recipients, as part of a Phase 3 clinical trial. It is a small molecule therapeutic developed by Novartis AG.
Calcineurin inhibitors target the enzyme calcineurin, which plays a role in activating T-cells of the immune system. By inhibiting calcineurin, the drug suppresses the immune response, which is important in preventing organ rejection after transplantation. This mechanism is relevant for its use in liver transplant patients.
Calcineurin inhibitors is developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research on this drug for the indication of liver transplantation.
Calcineurin inhibitors is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to evaluate the drug's efficacy and safety in liver transplant recipients with renal insufficiency.
Calcineurin inhibitors has one completed Phase 3 clinical trial with the identifier NCT00267189, titled 'RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency'. The trial enrolled 145 participants and was conducted in Germany and Switzerland. It was an active-controlled, randomized study, though not double-blinded.
Calcineurin inhibitors is a class of drugs, and the specific drug studied in the clinical trial is Everolimus. The trial NCT00267189 evaluates Everolimus, which is a type of calcineurin inhibitor. Therefore, in the context of this trial, Calcineurin inhibitors refers to Everolimus.