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

NCT ID: NCT02493465

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Left Ventricular Hypertrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

LVH everolimus

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

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.

Interventions

Everolimus

Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Urologia e Nefrologia

OTHER

Sponsor Role: lead

Responsible Party

MARIO ABBUD FILHO

MD PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto de Urologia e Nefrologia

São José do Rio Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Mario Abbud, MD.PhD

Role: primary

mabbud@terra.com.br

551740099165

Ananda F Calori

Role: backup

estudos@iun.com.br

551740099167

Other Identifiers

CRAD001ABR33T

Identifier Type: -

Identifier Source: org_study_id