Status:
COMPLETED
Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants
Lead Sponsor:
Edoardo Melilli
Conditions:
Hypertrophy, Left Ventricular
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 trans...
Detailed Description
A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrol...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03415750
Start Date
November 1 2016
End Date
May 1 2020
Last Update
January 8 2021
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907