Left ventricular hypertrophy in renal transplant patients in the maintenance phase . MedDRA version: 19.0 Level: PT Classification code 10049773 Term: Left ventricular hypertrophy System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Certican
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Other descriptive name: RAD001
Concentration unit: µg/l microgram(
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE - IDIBELL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient’s signed informed consent prior to any study-related procedure. - Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution. - Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA. -Patients with Left Ventricular Hypertrophy detected by Cardio-NMR. -Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation 0.5 g/day) -Patients with Hb levels = 11 gr/dl. -Patients with blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: -Patient is currently receiving aldosterone blockers and/or ACEi and/or ARB. -Presence of hyperdynamic arteriovenous fistula (non-distal AVF). -Proteinuria > 0.5 g/day in 24 hour urine. - Cardiovascular event (hemorrhagic or ischemic stroke, acute myocardial infarction with or without revascularization, amputation, lower limb ischemia) in the 6 months prior to the inclusion in the study. - Patient who presented severe chronic rejection (> IA according to Banff criteria) and / or presence of high immunological risk at the time of renal transplantation and / or inclusion in the study (presence of DSA) - Patient with recurrence of glomerulonephritis after renal transplantation. - Female subjects of child bearing potential who are pregnant or breast feeding, or who are unable or unwilling to use a medically acceptable form of contraception during their participation in the study. -Any other medical condition that, in the opinion of the investigator, based on the count or review of medical records, could affect the completion of the study, including, but not limited to, visual problems or cognitive impairment. -Recipient of a multi-organ transplant or an ABO incompatible kidney. -Nuclear magnetic resonance contraindication (pacemakers, metal implants, etc). -Patient is receiving other immunosuppression treatment than Envarsus® and MMF/MPA. -Known allergy to iodinated contrast agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that immunosuppressant combination based on tacrolimus + everolimus in stable renal transplant patients (> 12 months after transplant) achieves a greater reduction of left ventricular hypertrophy (LVH) compared to the “standard” combination based on tacrolimus + mycophenolate mofetil;Secondary Objective: To determine that the study combination improves cardiovascular profile by evaluating the improvement of pulse wave velocity,blood pressure, the measurement of intra-aortic pressure and determination of major cardiovascular events To demonstrate that the study combination improves kidney function by measuring serum creatinine, calculated GFR and clearance of iohexol To compare the CV and immunological profile in the two treatment groups using the following biomarkers: HbA1c, troponin I, NT-proBNP, CRP, FGF23 and development of donor specific antibodies (DSA). Markers related to myocardial fibrosis and arterial stiffness are also assessed: MMP-2, -9, PIINP, CITP To compare efficacy between the two treatment groups assessing: BPAR, graft loss, death and loss to follow up. To assess the safety of the combination by evaluating adverse events (AEs), Diabetes Mellitus and lipid profile;Primary end point(s): The primary endpoint is the measurement of left ventricular hypertrophy (LVH) in the two treatment groups by Cardio-NMR, through the calculation of left ventricular mass indexed (LVMI) defined as: LVMI > 91 g/m2 (men) LVMI > 78 g/m2 (women);Timepoint(s) of evaluation of this end point: MONTH 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical measurements: weight, height, BMI, waist circumference. - Pulse Wave Velocity (PWV). - Measurement of blood pressure (ABPM). - Study Pharmacokinetics (PK) tacrolimus + everolimus group - Major cardiovascular events (MACE). - Cardiovascular Biomarkers (CV). - Renal function (Clearance). - Acute rejection - proven by biopsy (BPAR). - Graft survival. - Survival of the patient. - Loss of follow-up.;Timepoint(s) of evaluation of this end point: MONTH 12 | — |
Countries
Spain
Contacts
Public ContactEDOARDO MELILLI
HOSPITAL UNIVERSITARI DE BELLVITGE
Outcome results
None listed