NCT01663805

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

Effects of the Use of "de Novo" Everolimus for the Expression of Cytokines in Kidneys From Extended Criteria Donors and With Delayed Graft Function

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: MARIO ABBUD FILHO · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 80 patients will participate in the study, being distributed into 4 groups of 20 individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive therapy with TAC, no statistical power analysis could be performed a priori. Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk factors: history of systemic hypertension terminal creatinine levels \> 1.5 mg/dL or death by a cerebrovascular accident. DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after transplantation.

Conditions

• Delayed Function of Renal Transplant

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2012-08-13
• Last updated: 2012-08-13

Locations

3 sites across 1 country: Brazil