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

Hospital de Clinicas de Porto Alegre

Status and phase

Unknown

Phase 4

Conditions

Kidney Transplant Recipients

Treatments

Drug: Tacrolimus

Drug: Everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01608412

CRAD001ABR19T

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Tacrolimus

Active Comparator group

Description:

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

Treatment:

Drug: Tacrolimus

Everolimus

Active Comparator group

Description:

Treatment:

Drug: Everolimus