Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daclizumab · 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...
Daclizumab is an investigational drug being studied for use in renal transplantation. It is being evaluated in a Phase 3 clinical trial to compare the efficacy and safety of different immunosuppressive regimens in renal transplant recipients. The drug is still in clinical development and has not been approved for this indication.
Daclizumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this drug for renal transplantation, with the drug currently in Phase 3 development.
Daclizumab is in Phase 3 clinical development for renal transplantation. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug remains in clinical development.
Daclizumab is associated with one completed Phase 3 clinical trial, NCT02686619. This trial studied the efficacy and safety of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, compared to mycophenolate mofetil with long-term cyclosporine continuation, in renal transplant recipients. The trial enrolled 237 participants in France.
Daclizumab is the drug name provided, and no alternative names have been reported. It is being studied for renal transplantation and is in Phase 3 development by Roche Holding AG. The drug is a small molecule therapeutic.