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

Instituto de Urologia e Nefrologia

Status and phase: Unknown; Phase 4

Conditions: Left Ventricular Hypertrophy

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02493465

CRAD001ABR33T

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

LVH everolimus

Experimental group

Description:

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

Treatment:

Drug: Everolimus