Phase
Condition
Glomerulonephritis
Treatment
SHR-2010 Injection
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to provide a written informed consent
Renal biopsy confirmed primary IgA nephropathy
24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
eGFR≥30 mL/min/ 1.73m2
40kg≤ Weight ≤100kg
Has been treated with optimized supportive treatment. (ACEI or ARB to maximumrecommended dose or maximum tolerated dose).
Exclusion
Exclusion Criteria:
systemic disease which may cause secondary IgA deposition in the mesangial region
Specific type of IgA nephropathy
History of severe opportunistic infection
A history of chronic or recurrent infection within 1 year prior to screening
History of active digestive system within one year
Have a malignant tumor or a history of malignant tumor
Subjects who have received organ transplants
Associated with other serious or poorly controlled systemic diseases
Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks beforescreening or during run-in period.
Received any systemic glucocorticoid 8 weeks before screening or during run-inperiod
Study Design
Connect with a study center
General Hospital of Eastern Theater Command
Nanjing, Jiangsu 210002
ChinaSite Not Available
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