24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

Novartis Pharmaceuticals71 enrolled

Overview

The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplant

Interventions

EverolimusDRUG

Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.

TacrolimusDRUG

Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.

Mycophenolic acid (MPA)DRUG

Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Received kidney transplant \> 6 months and \< 3 years prior to study enrollment * Receiving immunosuppressive regimen that includes tacrolimus and mycophenolic acid * Between 18 and 70 years of age * Willing to provide written informed consent Exclusion Criteria: * Patients with an actual serum creatinine ≥ 2 mg/dl and/or eGFR≤ 40 ml/min and/or proteinuria≥ 500mg/day * Patients who suffered from severe humoral and/or cellular rejection (≥ BANFF IIb, recurrent acute rejection or steroid resistant acute rejection in the previous years * Patients who have severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable. * Diabetic patients * Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception * Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements * Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study * Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment

Locations (9)

Novartis Investigative Site

Málaga, Andalusia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Outcomes

Primary Outcomes

Change From Baseline in Left Ventricular Mass Index (LVMI)

Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as \> 49.2 g/m\^2.7 in men and \>46.7 g/m\^2.7 in women. A negative change from baseline indicates improvement.

Time frame: Baseline, Month 24

Secondary Outcomes

Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure

Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.

Time frame: Baseline, Month 6, month 12, month 24

Pulse Wave Velocity (PWV)

Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.

Time frame: Month 6, month 24

Percentage of Participants With Major Cardiovascular Events (MACE)

The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.

Time frame: Month 24

Renal Function Measured by Serum Creatinine

Serum samples were collected to analyze serum creatinine.

Time frame: Month 6, month 12, month 24

Renal Function as Measured by Creatinine Clearance

Creatinine clearance was calculated using the Cockroft-Gault formula.

Data from ClinicalTrials.gov

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