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Also known as Cyclosporine
Neoral · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Corticosteroids | DRUG | As prescribed |
| Neoral | DRUG | Low dose (target trough level 50-100ng/mL) |
| Zenapax | DRUG | 2mg/kg iv first dose, then 1mg/kg every 2 weeks |
| mycophenolate mofetil [CellCept] | DRUG | 1g po bid |
Inclusion Criteria: * adult patients greater than 18 years of age * recipients of primary kidney transplant * single-organ recipients (kidney only) Exclusion Criteria: * previous treatment with Zenapax * history of malignancy (except localized skin cancer)
Neoral is used in kidney transplantation. It is a small molecule medicine developed by Roche Holding AG for use in nephrology, specifically in patients receiving a kidney transplant. The clinical program for this indication includes a completed Phase 3 study that enrolled 539 participants.
Neoral is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor associated with the kidney transplantation development program for this small molecule therapy.
Neoral has been studied in Phase 3 for kidney transplantation. The development program includes one completed Phase 3 trial, and no trials for this indication are currently listed as active. The completed study was randomized and controlled.
Neoral was evaluated in the Phase 3 study NCT00048152, titled A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients. The trial enrolled 539 participants, was randomized and controlled, and has been completed.
The Phase 3 trial NCT00048152 for Neoral in kidney transplantation was conducted across multiple countries, including the United States, Australia, Belgium, Canada, France, Germany, Mexico, Norway, Poland, Spain, Sweden, and the United Kingdom. It enrolled 539 participants aged 18 years and older, with no healthy volunteers included.