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

Edoardo Melilli

Status and phase: Completed; Phase 4

Conditions: Hypertrophy, Left Ventricular

Treatments: Drug: Mycophenolate mofetil; Drug: Tacrolimus; Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT03415750

ENHVIE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Everolimus arm

Experimental group

Description:

Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'

Treatment:

Drug: Everolimus

Drug: Tacrolimus

Mycophenolate arm

Active Comparator group

Description:

Patients will remain in Tacrolimus + Mycophenolate mofetil combination

Treatment:

Drug: Tacrolimus

Drug: Mycophenolate mofetil