802
Participants
Start Date
July 31, 2007
Primary Completion Date
June 30, 2015
Study Completion Date
June 30, 2015
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
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)"
Sandimmun Optoral
1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level
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
Novartis Investigative Site, Bern
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Lübeck
Novartis Investigative Site, Hanover
Novartis Investigative Site, Hannover Muenden
Novartis Investigative Site, Essen
Novartis Investigative Site, Cologne
Novartis Investigative Site, Aachen
Novartis Investigative Site, Frankfurt am Main
Novartis Investigative Site, Kaiserslautern
Novartis Investigative Site, Heidelberg
Novartis Investigative Site, Freiburg im Breisgau
Novartis Investigative Site, München
Novartis Investigative Site, München
Novartis Investigative Site, Erlangen
Novartis Investigative Site, Regensburg
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY