Evaluating HSK39297 tablets for treating IgA Nephropathy

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

This study is testing if HSK39297 tablets can help adults with IgA Nephropathy feel better and improve their kidney health compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06670352 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of HSK39297 tablets in patients diagnosed with primary IgA Nephropathy (IgAN). Participants will be administered either a placebo or varying doses of HSK39297 (50mg twice daily, 100mg twice daily, or 200mg once daily) to determine the optimal treatment regimen. The study will include adult patients who meet specific eligibility criteria, including a biopsy-confirmed diagnosis of IgAN and certain levels of proteinuria and kidney function. The trial will monitor participants for safety and treatment outcomes over a defined period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with biopsy-verified IgA Nephropathy and specific proteinuria levels.

Not a fit: Patients with other organ transplants or those currently using investigational drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from IgA Nephropathy.

How similar studies have performed: While there have been studies on IgA Nephropathy treatments, the specific approach with HSK39297 is novel and has not been extensively tested.

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 five years.
5. Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.

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), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
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 and 1 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)

Conditions IgA Nephropathy