Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mycophenolate mofetil and tacrolimus · 1 trial · 1 indication
Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)\*, (2) graft loss\*\*, (3) participant death or(4) loss to follow-up. \*A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. \*\*Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.
| Arm | Type | Description |
|---|---|---|
| Everolimus (EVR) & low dose of tacrolimus | EXPERIMENTAL | Everolimus (EVR) and tacrolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was \< 3 ng/mL, or reduced if the trough level was \> 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. |
| Mycophenolate mofetil & standard dose tacrolimus | ACTIVE_COMPARATOR | Mycophenolate mofetil and tacrolimus (MMF) treatment arm: MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. Tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, target level of tacrolimus was reduced to 5 - 8 ng/mL. |
| Name | Type | Description |
|---|---|---|
| Everolimus and tacrolimus | DRUG | Everolimus: * Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets * Dose: 1.5 mg per day * Frequency: 0.75 mg twice daily Tacrolimus: * Dose adjusted to maintain specific blood levels |
| mycophenolate mofetil and tacrolimus | DRUG | Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels |
Inclusion criteria: * Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant; * Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-H...
Mycophenolate Mofetil is used in kidney transplantation to prevent graft rejection. It is being studied in Phase 3 clinical trials for kidney transplant recipients, where it is compared against other immunosuppressive regimens to evaluate its efficacy and safety in preventing organ rejection.
Mycophenolate Mofetil is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's use in kidney transplantation and graft rejection prevention.
Mycophenolate Mofetil is in Phase 3 clinical development for kidney transplantation and graft rejection. It has completed multiple Phase 3 trials, including studies with over 700 participants, though it remains an investigational drug in this context and is not yet approved for these indications.
Mycophenolate Mofetil has been evaluated in completed Phase 3 trials including NCT00300274, which studied heart transplant recipients to prevent graft rejection with 721 participants, and NCT00658320, a renal transplant study in Japan with 122 participants. Another trial, NCT01025817, compared it to everolimus in kidney transplant recipients.
Mycophenolate Mofetil is the generic name for the drug originally marketed as CellCept by Roche. However, the data provided does not mention CellCept or any alternative brand names, so no equivalence can be confirmed from the available information.