Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prograf or Neoral · 1 trial · 1 indication
Assessment of renal function by comparing change from randomization to Month 12 in eGFR (MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR \[mL/min/1.73m˄2\] = 186.3\*(C˄-1.154)\*(A˄-0.203)\*G\*R. DEFINITIONS: C = serum concentration of creatinine \[mg/dL\]; A = age \[years\]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1
| Arm | Type | Description |
|---|---|---|
| Everolimus | EXPERIMENTAL | Conversion from CNI to everolimus in combination with Myfortic and steroids |
| Calcineurin inhibitor, Prograf or Neoral | ACTIVE_COMPARATOR | Control arm: CNI continuation, either Prograf or Neoral in combination with Myfortic and steroids |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Early CNI to everolimus conversion |
| Prograf or Neoral | DRUG | Active CNI-based control (Prograf or Neoral) |
Inclusion Criteria at Baseline: * Male or female renal allograft recipients at least 18 years old. * Written informed consent. * Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor. * Cold ischemia time (CIT) \< 24 hours. * Negative pregnan...
Prograf or Neoral is used for kidney transplantation. It is a small molecule being developed by Novartis AG for patients receiving a kidney transplant. The drug is currently in Phase 3 clinical development for this indication, with one completed Phase 3 trial involving 828 participants.
Prograf or Neoral targets the immune system to prevent organ rejection in kidney transplant recipients. As a small molecule, it works by modulating immune responses, which is critical for the success of kidney transplantation. The drug is being evaluated for its efficacy and safety in this patient population.
Prograf or Neoral is developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the drug's use in kidney transplantation, with the most recent trial being a Phase 3 study.
Prograf or Neoral is in Phase 3 clinical development for kidney transplantation. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, NCT01114529, has been completed, and the drug is still undergoing evaluation for this indication.
Prograf or Neoral has one completed Phase 3 clinical trial, NCT01114529, titled 'Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients.' This trial enrolled 828 participants across multiple countries, including the United States, Germany, and India, and was an active-controlled, randomized study.
Prograf or Neoral are brand names for immunosuppressant drugs used in kidney transplantation. Prograf is the brand name for tacrolimus, and Neoral is the brand name for cyclosporine. Both are calcineurin inhibitors that help prevent organ rejection in transplant patients.