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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-center,Randomized,Open-label,12 Months Study,2 Parallel Group to Compare the Efficacy of Everolimus Combination + Tacrolimus in Regression of Left Ventricular Hypertrophy vs Tacrolimus + MMF in Renal Transplant Patients

Conditions
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Hypertrophy, Left Ventricular

Intervention / Treatment
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* Drug: Everolimus
* Drug: Mycophenolate mofetil
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus arm<br>Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus' | Drug: Everolimus<br>* Conversion from Mycophenolate mofetil to Everolimus<br>* Other names: Certican;Drug: Tacrolimus<br> <br> * Other names: Prograf;|
| Active Comparator: Mycophenolate arm<br>Patients will remain in Tacrolimus + Mycophenolate mofetil combination | Drug: Mycophenolate mofetil<br>* Patients will remain in Tacrolimus + Mycophenolate mofetil<br>* Other names: Cellcept;Drug: Tacrolimus<br> <br> * Other names: Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Left Ventricular Hypertrophy | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant