Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants

Phase 4

Completed

• Conditions: Hypertrophy, Left Ventricular
• Interventions: Drug: Everolimus; Drug: Mycophenolate mofetil; Drug: Tacrolimus

• Registration Number: NCT03415750
• Lead Sponsor: Edoardo Melilli

Brief Summary

Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

Detailed Description

A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-01-30
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient's signed informed consent prior to any study-related procedure.
• Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
• Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
• Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
• Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
• No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
• Patients with Hb levels ≥ 11 gr/dl.
• Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.

Exclusion Criteria

• Patient's signed informed consent prior to any study-related procedure.
• Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
• Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
• Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
• Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
• No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
• Patients with Hb levels ≥ 11 gr/dl.
• Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus arm	Tacrolimus	Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
Everolimus arm	Everolimus	Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
Mycophenolate arm	Mycophenolate mofetil	Patients will remain in Tacrolimus + Mycophenolate mofetil combination
Mycophenolate arm	Tacrolimus	Patients will remain in Tacrolimus + Mycophenolate mofetil combination

Primary Outcome Measures

Name	Time	Method
Reduction of Left Ventricular Hypertrophy	12 months	Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain