NCT03415750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

3.5 years

First QC Date

November 17, 2016

Last Update Submit

January 7, 2021

Conditions

Hypertrophy, Left Ventricular

Keywords

Renal transplant

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Study Arms (2)

Everolimus arm

EXPERIMENTAL

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

Drug: EverolimusDrug: Tacrolimus

Mycophenolate arm

ACTIVE COMPARATOR

Patients will remain in Tacrolimus + Mycophenolate mofetil combination

Drug: Mycophenolate mofetilDrug: Tacrolimus

Interventions

EverolimusDRUG

Conversion from Mycophenolate mofetil to Everolimus

Also known as: Certican
Everolimus arm
Mycophenolate mofetilDRUG

Patients will remain in Tacrolimus + Mycophenolate mofetil

Also known as: Cellcept
Mycophenolate arm
TacrolimusDRUG
Also known as: Prograf
Everolimus armMycophenolate arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Interventions

EverolimusMycophenolic AcidTacrolimus

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Edoardo Melilli, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator MD

Study Record Dates

First Submitted

November 17, 2016

First Posted

January 30, 2018

Study Start

November 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)