NCT02493465

Brief Summary

This is a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular hypertrophy will be investigated before and after conversion of azathioprine to everolimus. This study will evaluate as primary objectives: the prevalence of left ventricular mass hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability of everolimus to reduce left ventricular mass after conversion from Azathioprine, using sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR) at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 6, 2015

Last Update Submit

July 8, 2015

Conditions

Left Ventricular Hypertrophy

Keywords

everolimusleft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • Progression of left ventricular hypertrophy

    Progression of left ventricular hypertrophy will be mesure by MIR and echocardiography (systolic and end-diastolic diameter of the left ventricle, interventricular septum thickness in end diastole, thickness of the ventricular posterior wall of the left ventricle in end-diastole, left ventricular mass, percentage of left ventricular ejection fraction.

    12 months

Secondary Outcomes (3)

  • renal function

    3,6, 12 months

  • proteinuria

    3,6, 12 months

  • acute rejection episodies

    12 months

Study Arms (1)

LVH everolimus

EXPERIMENTAL

Progression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus.

Drug: Everolimus

Interventions

EverolimusDRUG

Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.

LVH everolimus

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years (black and white subjects);
  • Kidney transplant recipients of living donor or deceased with creatinine clearance (measured / estimated) \> 50 ml /L for at least 12 months, receiving azathioprine with or without calcineurin inhibitor with or without prednisone.

You may not qualify if:

  • The subject, in the opinion of the investigator, is not able to complete the study protocol;
  • Multiple organ transplant recipient;
  • Pregnant women
  • Breastfeeding and childbearing age without contraceptive method
  • Test for Positive immunodeficiency virus (HIV)
  • Treatment of acute rejection in the last 3 months
  • Glomerulonephritis new relapse
  • New or polyomavirus nephropathy
  • protein / creatinine ≤ 150 mg / mmol or 24h proteinuria\> 500mg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Urologia e Nefrologia

São José do Rio Preto, São Paulo, 15015-200, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Interventions

Everolimus

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PHD

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 9, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

BR(1)