93
Participants
Start Date
November 30, 2005
Primary Completion Date
March 31, 2013
Study Completion Date
March 31, 2013
Everolimus
Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).
Cyclosporin A (CsA)
The dose was based on the participants' blood level of C0h (80-150 ng/ml).
Tacrolimus
The dose was based on the participants' blood level of C0h (5-10 ng/ml).
Enteric Coated - Mycophenolate Sodium (EC-MPS)
The dose was ≥ 720 mg/day.
Corticosteroids
Corticosteroids were given according to local standard and/or the Investigators' discretion.
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Kiel
Novartis Investigative Site, Hanover
Novartis Investigative Site, Essen
Novartis Investigative Site, Münster
Novartis Investigative Site, Cologne
Novartis Investigative Site, Kaiserslautern
Novartis Investigative Site, Heidelberg
Novartis Investigative Site, Heilbronn
Novartis Investigative Site, Erlangen
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY