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

Left Ventricular Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02493465
• Other study ID #: CRAD001ABR33T
• Status: Recruiting
• Phase: Phase 4
• First received: July 6, 2015
• Last updated: July 8, 2015
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2015
• Source: Instituto de Urologia e Nefrologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Drug:
• Everolimus
Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.

Locations

Country	Name	City	State
Brazil	Instituto de Urologia e Nefrologia	São José do Rio Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Urologia e Nefrologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	renal function	GFR (creatinina clearance)	3,6, 12 months	No
Secondary	proteinuria	24h Proteinuria	3,6, 12 months	Yes
Secondary	acute rejection episodies	clinical and biopsy if acute rejection suspected	12 months	Yes