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Label indication CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants.
Also known as CellCept
Mycophenoate Mofetil · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Mycophenolate Mofetil + Cyclosporine | ACTIVE_COMPARATOR | Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months. |
| Mycophenolate Mofetil + Sirolimus | EXPERIMENTAL | Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study. |
| Name | Type | Description |
|---|---|---|
| Cyclosporine | DRUG | Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng/mL) during Day 0 to Week 4, and 800-1200 ng/mL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1/4 of the dose for 3 days, and then cyclosporine will be stopped. |
| Daclizumab | DRUG | Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg/kg on Day14. |
| Mycophenoate Mofetil | DRUG | Mycophenoate mofetil 1 gram (g) (2\*500mg tablets or 4\*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months. |
| Prednisolone | DRUG | Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg/kg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg/kg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months. |
| Sirolimus | DRUG | Sirolimus tablets will be given orally from week 12 to week 52, starting with loading dose of 10 mg daily for 2 days followed by 6 mg daily to adapt to trough concentrations of 8-15 ng/mL from week 12 to week 39, and 5-10 ng/mL from week 39 to week 52. |
Inclusion Criteria: * Receipt of a first cadaveric kidney graft * Antilymphocyte antibodies and panel reactive antibodies (PRA) less than 30 percent (%) (historical peak and/or current value) * Cold ischaemia time less than or equal to 36 hours Exclusion Criteria: * Kidney from a living donor; do...
Mycophenolate mofetil is used in renal transplantation, where it is studied as part of immunosuppressive regimens for kidney transplant recipients. The Phase 3 trial NCT02686619 evaluated it in renal transplant recipients in France, comparing a regimen with delayed sirolimus introduction and cyclosporine discontinuation against mycophenolate mofetil with long term cyclosporine continuation.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with mycophenolate mofetil. The brand name referenced in the clinical trial is Cellcept.
Mycophenolate mofetil is in Phase 3 development for renal transplantation. The Phase 3 study NCT02686619 has completed, enrolling 237 participants. It is an investigational-stage asset in this program rather than a newly approved product.
Mycophenolate mofetil has been studied in the Phase 3 trial NCT02686619, titled a study comparing efficacy and safety of mycophenolate mofetil (Cellcept) with delayed introduction of sirolimus and discontinuation of cyclosporine versus mycophenolate mofetil with long term cyclosporine continuation in renal transplant recipients. The trial is completed, enrolled 237 participants, was randomized and active-controlled, and was conducted in France.
Yes, Cellcept is the brand name used for mycophenolate mofetil. The Phase 3 trial NCT02686619 refers to the drug as mycophenolate mofetil (Cellcept), so searches for either name point to the same medicine.
The Phase 3 trial NCT02686619 enrolled 237 participants with renal transplantation as the condition studied. Enrollment was randomized and used an active-controlled design, with participants aged 18 years and older and no healthy volunteers included.