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:
NCT04020328
Eligibility Criteria:
Inclusion Criteria:
* 14 to 65 years old participants, No restrictions on gender or race
* Diagnosis of primary IgA nephropathy
* Renal biopsy within 6 months before screening. Renal pathology shows diffuse IgA deposition in the Mesangial area and dense deposition in the Mesangial area under electron microscope. glomeruli more than 8
* persistent proteinuria ≥ 1 g/24 hr (or urine protein/creatinine ratio ≥ 1.0 mg/g), eGFR at 25-50 ml/min/1.73 m2 (calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
* signed written consent; patients under 18 years old need to have legal guardians to sign informed consent at the same time
Exclusion Criteria:
* Secondary IgA nephropathy (such as lupus nephritis, Henoch-Schönlein purpura, hepatitis B associated glomerulonephritis, hepatitis C associated glomerulonephritis, liver cirrhosis and other autoimmune diseases)
* eGFR \< 25 ml/min/1.73m2 or eGFR \> 50 ml/min/1.73m2 (calculated by CKD-EPI formula)
* Special types of IgA nephropathy need to be excluded, such as crescent IgA glomerulonephritis (defined as the presence of crescents in over 50% of the glomeruli), or minimal lesions with IgA deposition
* Acute kidney injury within 3 months before screening
* Received immunosuppressive therapy within 3 months before screening
* Patients who had acute or chronic infections that need treatment, and the researchers judged that they were not suitable for inclusion in the study
* Pregnancy, lactation or unreliable birth control
* Dialysis treatment before screening
* Allergic or taboo to planned drugs (such as leflunomide, glucocorticoids, etc.)
* Severe acute or chronic diseases that the researchers believe may bring an excessive risk to the subjects
* A history of malignant tumors within 5 years, with the exception of carcinoma in situ and papillary thyroid carcinoma which have been adequately treated
* Participated in other clinical trials and / or used other research drugs within 4 weeks prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT04020328
Study Brief:
Protocol Section:
NCT04020328