Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).

All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MARIO ABBUD FILHO
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Age ≥ 18 years (black and white subjects);

• End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)

• "Standard" traditional (SCD) or extended criteria (ECD) donor;

• Informed consent form duly signed before SCD or ECD kidney transplantation.

Exclusion criteria:

• The subject, in the opinion of the investigator, is not able to complete the study protocol;

• Recipient of live-donor kidney graft;

• Multiple organ transplant recipient;

• Evidence of large systemic or localized infection;

• Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;

• Use of any drug under investigation or treatment until up to 4 weeks before transplantation;

• Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;

• Immunosuppressive therapies in addition to those described for this study;

• Hypersensitized patients (PRA > 30%);

• Patients with HIV+ or Hepatitis B or C virus infection.

• Patients for whom T0 and T15 biopsies were not taken.