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

Sponsor
Edoardo Melilli (Other)
Overall Status
Completed
CT.gov ID
NCT03415750
Collaborator
(none)
20
1
2
42
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Everolimus arm

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

Drug: Everolimus
Conversion from Mycophenolate mofetil to Everolimus
Other Names:
  • Certican
  • Drug: Tacrolimus
    Other Names:
  • Prograf
  • Active Comparator: Mycophenolate arm

    Patients will remain in Tacrolimus + Mycophenolate mofetil combination

    Drug: Mycophenolate mofetil
    Patients will remain in Tacrolimus + Mycophenolate mofetil
    Other Names:
  • Cellcept
  • Drug: Tacrolimus
    Other Names:
  • Prograf
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona Spain 08907

    Sponsors and Collaborators

    • Edoardo Melilli

    Investigators

    • Principal Investigator: Edoardo Melilli, MD, Hospital Universitari de Bellvitge

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edoardo Melilli, Principal Investigator MD, Hospital Universitari de Bellvitge
    ClinicalTrials.gov Identifier:
    NCT03415750
    Other Study ID Numbers:
    • ENHVIE
    First Posted:
    Jan 30, 2018
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Edoardo Melilli, Principal Investigator MD, Hospital Universitari de Bellvitge
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 8, 2021