About this trial
This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.
Eligibility criteria
Qualifiers
Male or female, between 18 and 65 years age.
Biopsy-proven primary IgA nephropathy.
Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
Disqualifiers
IgA nephropathy secondary to another condition
IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
Chronic kidney disease (CKD) in addition to IgAN
Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing;
Trial design
Treatments tested in this trial
- HS-10390
- Irbesartan