Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Myfortic · 2 trials · 1 indication
Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted
| Arm | Type | Description |
|---|---|---|
| CNI standard regimen | ACTIVE_COMPARATOR | Myfortic, Sandimmun Optoral and corticosteroids |
| CNI free regimen | EXPERIMENTAL | CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids |
| CNI low regimen | ACTIVE_COMPARATOR | CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen |
| Myfortic | DRUG | 1 tablet containing 180 mg or 360 mg Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day) |
| Sandimmun Optoral | DRUG | 1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level |
| Simulect® | DRUG | Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4 |
Inclusion criteria * Males or females, aged 18 - 70 years * Recipients of de novo cadaveric, living unrelated or living related kidney transplants * Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an...
Myfortic is used for kidney transplantation. It is an investigational small molecule being developed by Novartis AG for patients who have undergone or are undergoing kidney transplantation. The drug is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities.
Myfortic is a small molecule developed for kidney transplantation. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied in Phase 3 trials to evaluate its effects in kidney transplant patients.
Myfortic is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in kidney transplantation.
Myfortic is in Phase 3 clinical development. It is an investigational drug for kidney transplantation and has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials have been completed, with a total enrollment of 1,144 patients.
Myfortic has been studied in two completed Phase 3 clinical trials. The first, NCT00101738, enrolled 342 kidney transplant patients across multiple countries. The second, NCT00514514, enrolled 802 patients in Germany and Switzerland, comparing standard regimens with calcineurin inhibitor-free and low-dose regimens.
Myfortic is the primary name used for this drug in clinical trials. No alternative names have been identified in the available information. The drug is being developed by Novartis AG under the name Myfortic for the indication of kidney transplantation.