NCT02493465

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Instituto de Urologia e Nefrologia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Ventricular Hypertrophy

Interventions

Type	Name	Description
DRUG	Everolimus	Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-07-01
• Completion: 2017-07-01
• First posted: 2015-07-09
• Last updated: 2015-07-09

Locations

1 site across 1 country: Brazil