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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Instituto de Urologia e Nefrologia

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Instituto de Urologia e Nefrologia

Dates:
Date Received: July 6, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: July 8, 2015
Last Verified: July 2015