Primary glomerular disease, IgA nephropathy
Conditions
Interventions
Experimental group:HSK39297 piece
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Completed the HSK39297-202 study and received 200mg QD HSK39297 after the investigator's comprehensive assessment The expected benefits of treatment outweigh the risks; 2.eGFR>=30ml/min/1.73m2 (calculated according to the CKD-EPI2021 formula) at screening; 3.Expected to continue to receive optimized RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine therapy for the duration of the study with stable prescriptions; 4.Neisseria meningitidis and Streptococcus pneumoniae vaccines as required by previous studies (if vaccine protection The treatment time limit of this study cannot be covered, and it needs to be met according to the vaccination guidelines and the requirements of the local vaccination institution Booster vaccination); 5.Female subjects of childbearing potential, must have a negative blood pregnancy test and must agree to be informed from the signature No attempt to become pregnant or donate for at least 30 days after the last dose of study drug ovarian and using highly effective contraception; Male subjects of childbearing potential must agree to sign the contract Sperm donation shall not be given until at least 90 days after the last dose of study drug, and shall not be given with the informed consent Their female partner uses highly effective contraception; 6.Those who understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Known or suspected hereditary or acquired complement deficiency; 2.History of currently active primary or secondary immunodeficiency; 3.History of bone marrow/hematopoietic stem cell or solid organ transplantation (e.g., heart, lung, kidney, liver); 4.History of malignancy within the past 5 years (except for cured basal cell carcinoma of the skin or cervical cancer in situ); 5.Previous history of recurrent invasive infection with capsular bacteria (such as Neisseria meningitidis, Streptococcus pneumoniae, etc.) or Mycobacterium tuberculosis; 6.Concomitant significant diseases, including but not limited to severe systemic active infection, advanced cardiac disease, severe pulmonary disease, or severe liver disease, and are judged by the investigator to be unsuitable for participation in the study; 7.Suspected allergy to the study drug or similar drugs; 8.Pregnant or lactating women; 9.There is a risk that may interfere with the conduct of the study, add additional risk to the subject, or other conditions that are assessed by the investigator to be unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the long-term safety of HSK39297 tablets in the treatment of patients with primary IgA nephropathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of 24h-UPCR at 12-week intervals during the treatment period from baseline;The value of eGFR estimated at every 24 weeks interval during the treatment period from baseline change;Proportion of patients with microscopic hematuria at intervals of 12 weeks during the treatment period;Change from baseline in the Functional Assessment of Chronic Disease Treatment-Fatigue (FACIT-F) scale score every 12 weeks during the treatment period;The ratio of 24h-UPE at 12-week intervals during the treatment period from baseline; | — |
Countries
China
Contacts
Public ContactHong Zhang
Peking University First Hospital
Outcome results
None listed