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New drug aims to slow kidney damage in IgA nephropathy

NCT ID NCT07390123

Disease control Sponsor: Haisco Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental tablet called HSK39297 in 370 adults with IgA nephropathy, a kidney disease. The goal is to see if the drug can reduce protein in the urine and slow down kidney function decline over 36 to 48 weeks. Participants will be randomly assigned to receive either the drug or a placebo, and neither they nor their doctors will know which they are getting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 370 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IgA nephropathy (IGAN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huangshan City People's Hospital

    RECRUITING

    Huangshan City, Anhui, China

  • Linyi City People Hospital

    RECRUITING

    Linyi, Shandong, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • The Second Affiliated Hospital of Wannan Medical College

    RECRUITING

    Wuhu, Anhui, China

  • The Second Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Xijing Hospital

    RECRUITING

    Xi’an, Shanxi, China

  • Zhanjiang Central Hospital

    RECRUITING

    Zhanjiang, Guangdong, China

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