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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT02682459
Eligibility Criteria:
Inclusion Criteria:
* Rapidly progressive renal failure associated with acute nephritic syndrome and/or nephrotic syndrome;
* Histology evidence of extracapillary proliferation with less than 50% of sclerotic glomeruli and associated with:
1. Type I: Anti-Glomerular Basement Membrane (GBM) antibody glomerulonephritis,
2. Type II: Pauci-immune vasculitis or Anti Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis;
3. Type III: Immune-complex mediated glomerular diseases: Proliferative lupus nephritis (LN), IgA nephropathy (IgAN)/ Schönlein-Henoch purpura, Type I membranoproliferative glomerulonephropathy (MPGN), Primary or secondary membranous nephropathy (MN), Primary or idiopathic immune complex glomerulonephritis.
* Clinical indication to immunosuppressive therapy;
* No specific indication to treatment with Renin Angiotensin System (RAS) inhibitors such as heart failure or coronary ischemic disease;
* Written informed consent.
Exclusion Criteria:
* Pre-existing advanced chronic renal failure (creatinine clearance less than 20 ml/min/1.73m2);
* Evidence of B or C virus active infection;
* HIV infection;
* Recent diagnosis of malignancy;
* Prolonged bleeding time and any other contraindication to kidney biopsy evaluation;
* Any specific contraindication to ACE inhibitor therapy (that is: history of angioedema or other treatment-related serious adverse events);
* Pregnancy or lactating;
* Women of childbearing potential without following a scientifically accepted form of contraception;
* Inability to understand the risks and benefit of the study or evidence of an uncooperative attitude;
* Legal incapacity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02682459
Study Brief:
Protocol Section:
NCT02682459