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

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ClinicalTrials.gov Identifier: NCT03415750
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Edoardo Melilli, Hospital Universitari de Bellvitge

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
Hypertrophy, Left Ventricular Drug: Everolimus Drug: Mycophenolate mofetil Drug: Tacrolimus 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


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 Name: Certican

Drug: Tacrolimus
Other Name: Prograf

Active Comparator: Mycophenolate arm
Patients will remain in Tacrolimus + Mycophenolate mofetil combination
Drug: Mycophenolate mofetil
Patients will remain in Tacrolimus + Mycophenolate mofetil
Other Name: Cellcept

Drug: Tacrolimus
Other Name: Prograf




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415750


Contacts
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Contact: Edoardo Melilli, MD 0034932607385 emelilli@bellvitgehospital.cat

Locations
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Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Edoardo Melilli, MD    0034932607385    emelilli@bellvitgehospital.cat   
Sponsors and Collaborators
Edoardo Melilli
Investigators
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Principal Investigator: Edoardo Melilli, MD Hospital Universitari de Bellvitge

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Responsible Party: Edoardo Melilli, Principal Investigator MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03415750     History of Changes
Other Study ID Numbers: ENHVIE
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edoardo Melilli, Hospital Universitari de Bellvitge:
Renal transplant

Additional relevant MeSH terms:
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Hypertrophy
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Tacrolimus
Everolimus
Sirolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents