IgA Nephropathy (IgAN)Phase 3NCT07390123
Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
A Phase 3 study testing HSK39297 in people with IgA Nephropathy (IgAN), run by Haisco Pharmaceutical Group Co., Ltd. at 9 sites in China.
Trial summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- HSK39297
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 9 sitesChina
- Study dates
- 7 Apr 2026to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Female and male patients above 18 years of age.
- 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
- Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
- 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
- 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.
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
- All transplanted patients (any organ, including bone marrow).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
- 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.
- Pregnant or nursing (lactating) women.
- Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hong Zhang, M.D., 13811123738, hongzh@bjmu.edu.cn
Hong Zhang, M.D.
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
Huangshan City People's Hospital
Huangshan City, Anhui
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
Linyi City People Hospital
Linyi, Shandong
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
Xijing Hospital
Xi’an, Shanxi
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
- Recruiting
Zhanjiang Central Hospital
Zhanjiang, Guangdong
Chao Wang, 86+13851803148, wangchaoyf@haisco.com
About this study
Official title: 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
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- HSK39297, Placebo
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK39297Drug
HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.
PlaceboDrug
Placebo, once a day; treatment period; 48-weeks fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| HSK39297 200mgQD | Experimental | Not described Receives: Drug: HSK39297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks
Measured: From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 48 weeks
Measured: From week 1 to week 48
Secondary outcomes (3)
Annualized total estimated Glomerular Filtration Rate slope over 36 weeks
Measured: From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 104 weeks
Measured: From week 1 to week 104
Incidence , severity and relationship of adverse events during the study period
Measured: From week 1 to week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start7 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390123
- Sponsor's protocol ID
- HSK39297-303
- Status last verified
- May 2026
- First submitted
- 29 Jan 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07390123
- Acronym / sponsor ID
- HSK39297-303
- Conditions
- IgA Nephropathy (IgAN)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| HSK39297 200mgQD | Experimental | Drug: HSK39297 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Female and male patients above 18 years of age.
- 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
- Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
- 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
Key exclusion criteria (6 listed)
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
- All transplanted patients (any organ, including bone marrow).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
- 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.
- Pregnant or nursing (lactating) women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK39297HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose. | Drug | HSK39297 200mgQD |
| PlaceboPlacebo, once a day; treatment period; 48-weeks fixed dose. | Drug | Placebo |
Primary outcome
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
Annualized total estimated Glomerular Filtration Rate slope over 48 weeks
Time frame: From week 1 to week 48
3 secondary outcomes
Annualized total estimated Glomerular Filtration Rate slope over 36 weeks
Time frame: From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 104 weeks
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK39297 in people with IgA Nephropathy (IgAN), run by Haisco Pharmaceutical Group Co., Ltd. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weifang Zeng (+8602867258840, zengwf@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.