IgA Nephropathy (IgAN)
Conditions
Brief summary
This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.
Interventions
DRUGHSK39297 200mgQD
Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.
DRUGHSK39297 300mgQD
Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297. 2. eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation). 3. Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study. 4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed). 5. Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose. Fertile males: highly effective contraception from signing informed consent until 90 days after last dose. 6. Voluntarily provided written informed consent and able to comply with study procedures
Exclusion criteria
1. Known or suspected hereditary or acquired complement deficiency. 2. Active primary or secondary immunodeficiency. 3. History of bone marrow / hematopoietic stem cell or solid organ transplantation. 4. Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). 5. History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis. 6. Severe concomitant diseases judged by the investigator to be incompatible with study participation. 7. Suspected hypersensitivity to the investigational product or its class. 8. Pregnant or lactating females. 9. Other conditions that may interfere with the study or increase subject risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) during treatment. | 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of 24-h urine protein-to-creatinine ratio (24h-UPCR) from baseline every 12 weeks during treatment | 48 weeks | — |
| Ratio of 24-h urine protein excretion (24h-UPE) from baseline every 12 weeks during treatment | 48 weeks | — |
| Change in estimated glomerular filtration rate (eGFR) from baseline every 24 weeks during treatment. | 48 weeks | — |
| Proportion of subjects with hematuria every 12 weeks during treatment. | 48 weeks | — |
| Change in Functional Assessment of Chronic Illness FACIT-F(Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline every 12 weeks during treatment | 48 weeks | The scale consists of 13 items, assessing patients' fatigue levels over the past seven days as well as fatigue impacts on cognition, physical function, psychology and social interaction. The total score is the sum of scores for all items, ranging from 0 to 52. A higher score indicates a lower degree of fatigue. |
Countries
China
Contacts
CONTACTli fangqiong Li
Outcome results
None listed