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

Primary Purpose

Hypertrophy, Left Ventricular

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Everolimus
Mycophenolate mofetil
Tacrolimus
Sponsored by
Edoardo Melilli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophy, Left Ventricular focused on measuring Renal transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Everolimus arm

Mycophenolate arm

Arm Description

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

Patients will remain in Tacrolimus + Mycophenolate mofetil combination

Outcomes

Primary Outcome Measures

Reduction of Left Ventricular Hypertrophy
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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2016
Last Updated
January 7, 2021
Sponsor
Edoardo Melilli
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1. Study Identification

Unique Protocol Identification Number
NCT03415750
Brief Title
Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants
Acronym
ENHVIE
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edoardo Melilli

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy, Left Ventricular
Keywords
Renal transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus arm
Arm Type
Experimental
Arm Description
Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
Arm Title
Mycophenolate arm
Arm Type
Active Comparator
Arm Description
Patients will remain in Tacrolimus + Mycophenolate mofetil combination
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Certican
Intervention Description
Conversion from Mycophenolate mofetil to Everolimus
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
Cellcept
Intervention Description
Patients will remain in Tacrolimus + Mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf
Primary Outcome Measure Information:
Title
Reduction of Left Ventricular Hypertrophy
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo Melilli, MD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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