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

Study Overview
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Brief Summary
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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.

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

Conditions
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Left Ventricular Hypertrophy

Intervention / Treatment
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* Drug: Everolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LVH everolimus<br>Progression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus. | Drug: Everolimus<br>* Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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everolimus, left ventricular hypertrophy