A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypotheses to be tested in this study are:

• Conversion to everolimus at 3 months post-transplantation is safe and effective;

• Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;

• Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.

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

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;

• Older than 18 years;

• Panel-reactive antibodies lower than 20%;

• Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.

Exclusion Criteria:

• eGFR < 35 mL/min at randomization;

• Urine protein-to-creatinine ratio > 0.8 at randomization;

• Episode of acute rejection with Banff histological classification > 1A in the first 3 months post-transplant;

• Cholesterol > 350 mg/dL or triglycerides > 400 mg/dL with therapy at randomization;

• Active infection at randomization;

• Chronic liver disease;

• Refusal to participate in the study;

• Contraindications to kidney biopsy;

• Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.