Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

May 27, 2026 updated by: Haisco Pharmaceutical Group Co., Ltd.

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

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Huangshan City, Anhui, China
        • Recruiting
        • Huangshan City People's Hospital
        • Contact:
      • Wuhu, Anhui, China
        • Recruiting
        • The Second Affiliated Hospital of Wannan Medical College
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Hong Zhang, M.D.
    • Guangdong
      • Zhanjiang, Guangdong, China
        • Recruiting
        • Zhanjiang Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
    • Shandong
      • Linyi, Shandong, China
        • Recruiting
        • Linyi City People Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo, once a day; treatment period; 48-weeks fixed dose.
Experimental: HSK39297 200mgQD
Drug: HSK39297
HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks
Time Frame: From week 1 to week 36
From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 48 weeks
Time Frame: From week 1 to week 48
From week 1 to week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Annualized total estimated Glomerular Filtration Rate slope over 36 weeks
Time Frame: From week 1 to week 36
From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 104 weeks
Time Frame: From week 1 to week 104
From week 1 to week 104
Incidence , severity and relationship of adverse events during the study period
Time Frame: From week 1 to week 108
From week 1 to week 108

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSK39297-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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