Clinical Trials in China / NCT07390123
Recruiting
Phase 3
Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
NCT07390123 · tracked via the Priya Life Science China tracker
Condition(s) studied
IgA Nephropathy (IgAN)
Investigational drug(s) / intervention(s)
HSK39297 →Placebo
HSK39297: HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.
Placebo: Placebo, once a day; treatment period; 48-weeks fixed dose.
Study summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Huangshan City People's Hospital | Huangshan City | Anhui | Recruiting |
| The Second Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | Recruiting |
| Peking University First Hospital | Beijing | Beijing Municipality | Recruiting |
| Zhanjiang Central Hospital | Zhanjiang | Guangdong | Recruiting |
| Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| The Second Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Linyi City People Hospital | Linyi | Shandong | Recruiting |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | Recruiting |
| Xijing Hospital | Xi’an | Shanxi | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07390123 on ClinicalTrials.gov ↗ ← All trials in China