HSK39297 tablets for adults with primary IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Huangshan City People's Hospital
  Huangshan City, Anhui, China Recruiting
• The Second Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhanjiang Central Hospital
  Zhanjiang, Guangdong, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• The Second Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Weifang Zeng
• Email: zengwf@haisco.com
• Phone: +8602867258840

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JADE101 in IgA Nephropathy (phase 3, blinded)

  This phase 3 study tests whether JADE101 helps adults with IgA nephropathy more than a placebo.

  Recruiting at 4 sites Phase 3 Jade Biosciences, Inc. · Arvada, Colorado and 3 other locations · NCT07902817

• Personalized IgA Nephropathy treatment guided by Gd-IgA1 monitoring

  This study tests whether regularly checking a biomarker called Gd-IgA1 to guide treatment with Nefecon or telitacicept helps people with IgA nephropathy or related nephritis respond better.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07822100

• Long-term safety and effectiveness of HSK39297 tablets in IgA nephropathy patients who completed prior study

  This phase 2 trial tests whether taking HSK39297 once daily for IgA nephropathy is safe over the long term and helps reduce protein in the urine for patients who completed a previous study and meet criteria.

  Recruiting Phase 2 Haisco Pharmaceutical Group Co., Ltd. · Beijing and 1 other locations · NCT07616700

• Everest001: a medicine for certain kidney diseases to see if it helps adults

  This study tests EVER001 in adults with FSGS, MCD, or IgA nephropathy to see if it can help reduce protein in the urine and improve kidney function.

  Recruiting at 2 sites Phase 2 Everest Medicines (China) Co.,Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07614477

• Nefecon as a maintenance therapy to prevent relapse in IgA nephropathy

  This study tests whether continuing Nefecon after initial remission can lower the chance of relapse in adults with IgA nephropathy.

  Recruiting Phase 4 Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07604311

• CD19/BCMA UCART for B cell–related autoimmune diseases

  This early-stage study tests QT-219CX, a universal allogeneic CAR-T cell therapy that targets CD19 and BCMA, in people with refractory B-cell–related autoimmune diseases to see if it can be given safely and provide early signs of benefit.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07586267

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.