HSK39297 tablets for adults with primary IgA nephropathy

A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN

This trial will try HSK39297 tablets versus placebo to lower proteinuria and protect kidney function in adults with primary IgA nephropathy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07390123 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares HSK39297 tablets with matching placebo in adults who have biopsy‑proven primary IgA nephropathy and meet predefined proteinuria and kidney function thresholds. Eligible participants must have sufficient proteinuria at screening and an eGFR generally ≥30 mL/min/1.73 m2 (with limited exceptions for recent biopsies). Participants receive study medication and attend scheduled visits for laboratory tests and kidney assessments, including 24‑hour urine protein and eGFR monitoring. The trial is enrolling at Peking University First Hospital in Beijing, China.

Who should consider this trial

Good fit: Adults (≥18 years) with biopsy‑confirmed primary IgA nephropathy within the allowed timeframe, elevated 24‑hour proteinuria (≥0.75 g/g UPCR or ≥1.0 g/24 h) and adequate kidney function per the protocol are ideal candidates.

Not a fit: People under 18, those with very low eGFR below the study threshold, BMI ≥35 kg/m2, or recent use of other investigational drugs are unlikely to qualify or benefit from participation.

Why it matters

Potential benefit: If successful, HSK39297 could reduce proteinuria and slow progression of kidney damage in people with primary IgA nephropathy.

How similar studies have performed: Other treatments for IgA nephropathy (for example, optimal blood pressure/RAAS blockade and SGLT2 inhibitors) have shown clinical benefit, but HSK39297 represents a novel agent with limited prior public phase‑3 data.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Weifang Zeng

Conditions IgA Nephropathy