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

An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01608412

Enrollment

120

Registered

2012-05-31

Start date

2012-02-29

Completion date

2014-07-31

Last updated

2012-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

Keywords

renal transplantation, everolimus, tacrolimus, molecular evaluation

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.

Interventions

DRUGTacrolimus

TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred

DRUGEverolimus

Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Brazil

Contacts

Primary ContactLuiz Felipe S. Gonçalves, MD

lfgoncalves@hcpa.ufrgs.br

Backup ContactNisséia Jahn, RN

nisseia@yahoo.com.br

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026