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

Phase 4

• Conditions: Left Ventricular Hypertrophy
• Interventions: Drug: Everolimus

• Registration Number: NCT02493465
• Lead Sponsor: Instituto de Urologia e Nefrologia

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 Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09
• Primary Completion: 2016-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LVH everolimus	Everolimus	Progression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus.

Primary Outcome Measures

Name	Time	Method
Progression of left ventricular hypertrophy	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.

Secondary Outcome Measures

Name	Time	Method
renal function	3,6, 12 months	GFR (creatinina clearance)
proteinuria	3,6, 12 months	24h Proteinuria
acute rejection episodies	12 months	clinical and biopsy if acute rejection suspected

Trial Locations

Locations (1)

Instituto de Urologia e Nefrologia; 🇧🇷 São José do Rio Preto, São Paulo, Brazil