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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT05136456
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
2. Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)
3. PLA2R-Ab titer ≥20RU/mL at screening
4. 24-hour urinary protein ≥ 3.5g/d at screening
5. Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
Exclusion Criteria:
1. Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
2. Existence of clinically significant infection within 1 month before screening,
3. Severe or not well controlled other complications
4. Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
5. ALT \> 2 times ULN and/or AST \> 2 times ULN and/or bilirubin \>2 times ULN at screening
6. Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
7. Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05136456
Study Brief:
Protocol Section:
NCT05136456