Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00514514 | Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen | PHASE3 | COMPLETED | 802 | — | — | Jul 1, 2007 | Jun 1, 2015 | Jan 18, 2017 | 18 | Germany, Switzerland |
| NCT00101738 | Freedom Study: Myfortic in Kidney Transplant Patients | PHASE3 | COMPLETED | 342 | — | — | Mar 1, 2003 | May 1, 2005 | Jan 31, 2011 | 44 | United States, Argentina +11 |
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...