| Eligibility |
Inclusion Criteria:
1. Able and willing to provide a written informed consent;
2. Weight =35 kg, Body mass index (BMI) < 37.5kg /m2;
3. Primary IgA nephropathy was confirmed by renal biopsy within 5 years;
4. 24-UPE= 0.75g /24h, or UPCR= 0.8g/g at screening and prior to randomization;
5. eGFR=30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
6. A fertile female subject or a male subject whose partner is a fertile female, who has
not had a fertility, sperm/egg donation plan from the signing of the informed consent
to 1 month after the last dose, and voluntarily takes effective contraceptive measures
(including the partner);
7. Receiving optimal supportive therapy including RAS blockers for 12 weeks and
stabilizing the dose for at least 4 weeks after reaching the maximum recommended dose
or the maximum tolerated dose prior to randomization;
Exclusion Criteria:
1. Allergic to any RAS blockers, investigational products, or components as evaluated by
the investigator;
2. Patients with secondary IgA nephropathy as determined by the investigator;
3. 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%;
4. Patients with a history of immunodeficiency disease; Or in combination with other
systemic diseases likely to cause proteinuria;
5. Have any organ transplant;
6. Patients with chronic recurrent infections within 1 year prior to screening, such as
liver abscess and pyelonephritis; Or subjects with active infection who requiring
intravenous antibiotic therapy within 2 weeks prior to randomization;
7. Patients with a history of malignant neoplasms;
8. Patients with a history of severe trauma or major surgery within 12 weeks prior to
screening, or who plan to undergo surgery during the study period;
9. Patients with a history of blood donation or a history of severe blood loss (=400 mL
blood loss) within 12 weeks prior to screening, or who have received blood
transfusions within 12 weeks prior to screening;
10. The presence of a disease or medical condition determined by the investigator might
affect drug absorption, distribution, metabolism, and excretion;
11. As determined by the investigator, the subject has any of the following: progression
or recovery of a disease;
12. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin
exceeding 3 times the upper limit of normal (ULN) at screening;
13. Participants who have participated in a clinical trial of any drug or medical device
within 12 weeks prior to randomization and are expected to have residual effects of
the investigational treatment (as determined by the investigator), or who were within
the follow-up period of a clinical study, or within 5 half-lives of the
investigational drug, or within 30 days (whichever is older) before screening;
14. Women who are pregnant or breastfeeding;
15. A history of drug abuse;
16. Any physical or mental illness or condition that, as determined by the investigator,
is likely to increase the risk of the study, affect the subject's adherence to the
protocol, or prevent the subject from completing the study.
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