Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

PHASE3CompletedINTERVENTIONAL
Enrollment

802

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Kidney Transplantation
Interventions
DRUG

Everolimus

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

DRUG

Myfortic

"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)"

DRUG

Sandimmun Optoral

1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level

DRUG

Simulect®

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

Trial Locations (18)

3010

Novartis Investigative Site, Bern

10117

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

20246

Novartis Investigative Site, Hamburg

23538

Novartis Investigative Site, Lübeck

30625

Novartis Investigative Site, Hanover

34346

Novartis Investigative Site, Hannover Muenden

45122

Novartis Investigative Site, Essen

51109

Novartis Investigative Site, Cologne

52074

Novartis Investigative Site, Aachen

60596

Novartis Investigative Site, Frankfurt am Main

67655

Novartis Investigative Site, Kaiserslautern

69120

Novartis Investigative Site, Heidelberg

79106

Novartis Investigative Site, Freiburg im Breisgau

81377

Novartis Investigative Site, München

81675

Novartis Investigative Site, München

91054

Novartis Investigative Site, Erlangen

93053

Novartis Investigative Site, Regensburg

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY