A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
- Registration Number
- NCT01608412
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus Tacrolimus The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy. Intervention arm: Tacrolimus Everolimus Everolimus The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy. Intervention arm: Everolimus
- Primary Outcome Measures
Name Time Method Evaluate cumulative patient and graft survival at 12 months post conversion one year Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis
- Secondary Outcome Measures
Name Time Method Evaluation of estimated glomerular filtration rate 12 months post-conversion one year - To assess the efficacy of conversion from tacrolimus to everolimus 12 months post-conversion by measuring the estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) equation
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil