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

January 7, 2021 updated by: Edoardo Melilli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Everolimus arm
Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
Drug: Tacrolimus
Other Names:
  • Prograf
Drug: Everolimus
Conversion from Mycophenolate mofetil to Everolimus
Other Names:
  • Certican
ACTIVE_COMPARATOR: Mycophenolate arm
Patients will remain in Tacrolimus + Mycophenolate mofetil combination
Drug: Tacrolimus
Other Names:
  • Prograf
Drug: Mycophenolate mofetil
Patients will remain in Tacrolimus + Mycophenolate mofetil
Other Names:
  • Cellcept

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edoardo Melilli

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

May 1, 2020

Study Completion (ACTUAL)

May 1, 2020

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

January 29, 2018

First Posted (ACTUAL)

January 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENHVIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertrophy, Left Ventricular

Clinical Trials on Tacrolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe