Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT03415750
Eligibility 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 \<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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03415750
Study Brief:
Protocol Section:
NCT03415750