120
Participants
Start Date
December 31, 2012
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2017
Everolimus
Everolimus: initial dose of 1 mg twice a day starting at Day 1. Dose will be adjusted to keep everolimus trough levels between 3 and 8 ng/mL.
Very Low Tacrolimus
Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL during the first 3 months and 2 and 4 ng/mL thereafter.
Low Tacrolimus
Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL.
Steroids
Corticoids: endovenous Methylprednisolone will be administered 30-60 minutes before the first 3 doses of r-ATG: 250 mg (D0) and 125 mg (D2 and D4); Prednisone, 10 mg per oral, will be administered before the last dose of r-ATG (D6). Maintenance with Prednisone at post-transplant period will be performed in accordance with center local practice, i.e., only in patients with chronic previous use of corticosteroids, as well as in patients with autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, etc).
Thymoglobulin
All patients will receive induction with rabbit Thymoglobulin (r-ATG) in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg), administered according to center local practice (before graft revascularization and at days 2, 4, and 6 post-transplant).
Sodium Mycophenolate
Sodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1.
Hospital Geral de Fortaleza, Fortaleza
Collaborators (1)
Novartis Pharmaceuticals
INDUSTRY
Ronaldo de Matos Esmeraldo, MD
OTHER_GOV