NCT07390123 Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
| NCT ID | NCT07390123 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Condition | IgA Nephropathy (IgAN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 370 participants in total. It began in 2026-04-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07390123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IgA Nephropathy (IgAN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07390123 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 370 participants.
Is NCT07390123 currently recruiting?
Yes, NCT07390123 is actively recruiting participants. Contact the research team at zengwf@haisco.com for enrollment information.
Where is the NCT07390123 trial being conducted?
This trial is being conducted at Huangshan City, China, Wuhu, China, Beijing, China, Zhanjiang, China and 5 additional locations.
Who is sponsoring the NCT07390123 clinical trial?
NCT07390123 is sponsored by Haisco Pharmaceutical Group Co., Ltd.. The trial plans to enroll 370 participants.