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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04438603
Eligibility Criteria:
Inclusion Criteria:
1\. IgA nephropathy:
1. Age: 18-80 years.
2. Patients diagnosed with primary IgA nephropathy by renal biopsy.
3. Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m\^2.
4. Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity matched health volunteers. 3. IgAN patients were further divided into 4 groups, as defined below:
1\) Long-term stable patients:
Follow-up for at least 15 years and meet at least one of the following:
1. Annual eGFR loss rate \<3ml/min/1.73m\^2.
2. eGFR\>90ml/min/1.73m\^2. 2) Non-progressive IgAN patients:
Meet at least one of the following:
1. eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).
2. Annual eGFR loss rate \>5ml/min/1.73m\^2.
3. Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤ 1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of disease progression: Proteinuria \> 1g/24h despite 3 months of optimized supportive care.
Exclusion Criteria:
1. Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
2. Patients with secondary IgAN;
3. During pregnancy or lactation;
4. After kidney transplantation;
5. More than one serious acute infection in the psat 12 months;
6. Chronic infection;
7. Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;
8. Incomplete medical history or clinical data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04438603
Study Brief:
Protocol Section:
NCT04438603