A Trial of HRS-5965 Tablets in Primary IgA Nephropathy

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, whohas not had a fertility, sperm/egg donation plan from the signing of the informedconsent to 1 month after the last dose, and voluntarily takes effectivecontraceptive measures (including the partner);

7. Receiving optimal supportive therapy including RAS blockers for 12 weeks andstabilizing the dose for at least 4 weeks after reaching the maximum recommendeddose or the maximum tolerated dose prior to randomization;

Exclusion Criteria:

1. Allergic to any RAS blockers, investigational products, or components as evaluatedby the investigator;

2. Patients with secondary IgA nephropathy as determined by the investigator;

3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicatedthat more than 50% of the glomerulus had large crescent body formation, which mayaffect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;

4. Patients with a history of immunodeficiency disease; Or in combination with othersystemic diseases likely to cause proteinuria;

5. Have any organ transplant;

6. Patients with chronic recurrent infections within 1 year prior to screening, such asliver abscess and pyelonephritis; Or subjects with active infection who requiringintravenous 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 toscreening, 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 mLblood loss) within 12 weeks prior to screening, or who have received bloodtransfusions within 12 weeks prior to screening;

10. The presence of a disease or medical condition determined by the investigator mightaffect drug absorption, distribution, metabolism, and excretion;

11. As determined by the investigator, the subject has any of the following: progressionor recovery of a disease;

12. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubinexceeding 3 times the upper limit of normal (ULN) at screening;

13. Participants who have participated in a clinical trial of any drug or medical devicewithin 12 weeks prior to randomization and are expected to have residual effects ofthe investigational treatment (as determined by the investigator), or who werewithin the follow-up period of a clinical study, or within 5 half-lives of theinvestigational 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 theprotocol, or prevent the subject from completing the study.