Clinical trial NCT03415750: Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertrophy, Left Ventricular
Keywords: Renal transplant
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Reduction of Left Ventricular Hypertrophy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Edoardo Melilli, MD
role: PRINCIPAL_INVESTIGATOR
References: