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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT02644928
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70 years (male or female).
* BMI \>35 kg/m2 who meet the following criteria:
1. GFR 30-60 ml/min and proteinuria\>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
2. GFR \>60 ml/min and proteinuria \>(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
* Patients with BMI\> 40 kg/m2 with a GFR\> 30 ml/min and proteinuria \>(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
* Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document.
Exclusion Criteria:
* Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days.
* Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation.
* Patients with poorly controlled blood pressure (SBP\> 170 mmHg or DBP\> 110 mmHg).
* Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months.
* Patients treated with steroids or other immunosuppressants.
* Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use.
* Patients who are pregnant or lactating.
* Patients who do not sign the informed consent.
* A slight chance of compliance with visits scheduled in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02644928
Study Brief:
Protocol Section:
NCT02644928