IgA Nephropathy (IgAN)
Conditions
Brief summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Interventions
DRUGHSK39297
HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.
DRUGPlacebo
Placebo, once a day; treatment period; 48-weeks fixed dose.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study. 2. Female and male patients above 18 years of age. 3. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years. 5. 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening. 6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.For patients with eGFR\* 20 to \<30ml/min/1.73m2, a qualifying biopsy performed in two years.
Exclusion criteria
1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer. 2. All transplanted patients (any organ, including bone marrow). 3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer). 4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. 5. Pregnant or nursing (lactating) women. 6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks | From week 1 to week 36 |
| Annualized total estimated Glomerular Filtration Rate slope over 48 weeks | From week 1 to week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Annualized total estimated Glomerular Filtration Rate slope over 36 weeks | From week 1 to week 36 |
| Annualized total estimated Glomerular Filtration Rate slope over 104 weeks | From week 1 to week 104 |
| Incidence , severity and relationship of adverse events during the study period | From week 1 to week 108 |
Countries
China
Contacts
CONTACTWeifang Zeng
Outcome results
None listed