Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant

PHASE4CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2017

Conditions
Transplantation InfectionCytomegalovirus Infections
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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).

DRUG

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).

DRUG

Sodium Mycophenolate

Sodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1.

Trial Locations (1)

60175-295

Hospital Geral de Fortaleza, Fortaleza

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Ronaldo de Matos Esmeraldo, MD

OTHER_GOV