Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study

July 8, 2015 updated by: MARIO ABBUD FILHO, Instituto de Urologia e Nefrologia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Brazil
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15015-200
        • Recruiting
        • Instituto de Urologia e Nefrologia
        • Contact:
        • Contact:

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LVH everolimus
Progression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus.
Drug: Everolimus
Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of left ventricular hypertrophy
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal function
Time Frame: 3,6, 12 months
GFR (creatinina clearance)
3,6, 12 months
proteinuria
Time Frame: 3,6, 12 months
24h Proteinuria
3,6, 12 months
acute rejection episodies
Time Frame: 12 months
clinical and biopsy if acute rejection suspected
12 months

Collaborators and Investigators

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

Sponsor

Instituto de Urologia e Nefrologia

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

July 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (ESTIMATE)

July 9, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001ABR33T

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.

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