Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase

Phase 1

Active, not recruiting

• Conditions: eft ventricular hypertrophy in renal transplant patients in the maintenance phase .; MedDRA version: 19.0Level: PTClassification code 10049773Term: Left ventricular hypertrophySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002198-37-ES
• Lead Sponsor: HOSPITAL UNIVERSITARI DE BELLVITGE - IDIBE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <20%).
-No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
-Patients with Hb levels = 11 gr/dl.
-Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified