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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT02693366
Eligibility Criteria:
Inclusion Criteria:
* Patients with diagnosis of primary focal segmental glomerulosclerosis after having been previously treated with corticosteroids and immunosuppressive drugs and have not reached satisfactory answer. Will also be considered candidates those patients who performed late diagnosis and therefore no more clinical indication to perform therapy with corticosteroids and immunosuppressants. In both cases, showing irreversible loss of renal function with filtration rate between 40 - 20 ml/min.
* Patient should use the classical nephroprotective medication: angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker, or both.
Exclusion Criteria:
* Acute urinary tract infection;
* Urinary infection with tuberculosis bacillus or fungi;
* Patients with poorly anatomical formations of the urinary tract, polycystic kidney disease and other congenital or acquired kidney diseases.
* Blood pressure greater than 160 mm Hg systolic and 100 mmHg diastolic, in measurements taken during the last 3 outpatient visits;
* Who has performed examination with iodinated contrast the last 3 months
* Use of potentially nephrotoxic drugs;
* Use of corticosteroid therapy in immunosuppressive doses or more than 0.3 mg/kg/day
* Inability to obtain vascular access for endovascular procedure
* Sepsis (defined according to the Society of Critical Care Medicine, American College of Chest Physicians, 1992);
* Malignancies
* Autoimmune disorders,
* Neurodegenerative diseases;
* Acute heart failure or decompensated;
* Primary hematologic diseases;
* Osteopathies reflecting increased risk for spinal puncture;
* Coagulopathies;
* Liver failure;
* History of stroke or myocardial infarction in the last 6 months;
* Pregnancy or breastfeeding;
* History and serology of chronic infectious diseases, including HIV, Hepatitis C virus, Hepatitis B virus
* Participation in another clinical trial last year
* Cognitive impairment to understand all procedures
* Prolonged travel plans or domicile changes to other states that generate unable to attend the follow-up visits;
* Any other clinically significant active disease in the opinion of the principal investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02693366
Study Brief:
Protocol Section:
NCT02693366