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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edoardo Melilli
• Treatments: Everolimus; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

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.