IgANPhase 2HS-10542NCT07474636
Efficacy and Safety Study of HS-10542 for IgA Nephropathy
A Phase 2 study testing HS-10542 High Dose and HS-10542 Low Dose in people with IgAN and Immunoglobulin A Nephropathy (IgAN), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- IgAN, Immunoglobulin A Nephropathy (IgAN), Glomerular Disease
- What is being tested?
- HS-10542 High Dose and HS-10542 Low Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 30 Jan 2028
- Phase
- Phase 2
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.
- Body weight≥35kg, BMI<37.5kg/m2.
- Primary IgA nephropathy was confirmed by renal biopsy within 8 years.
- 24-hour urine protein excretion≥1.0g/24h, or UPCR≥0.8g/g at screening and prior to randomization.
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization；
- A fertile female participant or a male participant whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan and voluntarily takes highly effective contraceptive measures (including the partner).
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- All participants received RAS blocker treatment at least for 12 weeks, or demonstrated intolerance to RAS blockers, but has received SGLT2 inhibitors, endothelin receptor antagonists, or a mineralocorticoid receptor antagonist for at least 12 weeks, and have achieved the maximum recommended dose according to the product label or the maximum tolerated dose with stable dosing for at least 4 weeks prior to randomization.
- Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
Who cannot join
- Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
- Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria>3.5 g/day and serum albumin<3.0 g/dL, with or without edema);
- IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
- Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);
- Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.
- Participants with a medical history of invasive infections caused by capsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae;
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- Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or participants with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;
- Participants have a history of malignancy (except of radical excision of basal cell or squamous cell skin cancer, or cervical carcinoma in situ.), Participants with prior malignancy who have been documented to be cancer-free for≥5 years may be enrolled;
- Participants with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;
- Participants with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;
- Participants had received systemic glucocorticoid therapy, immunosuppressive agents (e.g. mycophenolate mofetil or calcineurin inhibitors), Chinese patent medicines with immunosuppressive properties (e.g. Tripterygium wilfordii tablets), or renin inhibitors within 12 weeks of randomisation. Alternatively, they were assessed by the investigator as potentially requiring such treatments during the study period.
- Participants had received treatment with biologics (e.g. telitacicept, atacicept, povetacicept, sibeprenlimab, CD38 monoclonal antibodies), or with budesonide enteric capsules (NEFECON) or cytokine inhibitors, as well as other products related to the complement pathway (e.g. eculizumab, ravulizumab and avacopan), which were not included in the investigational drug of this study within 6 months prior to randomisation, or participants had received iptacopan within 12 weeks prior to randomization;
- Participants have a history of gastrointestinal surgery that may significantly affect the absorption, distribution, metabolism or excretion of drugs. Or have a history of severe gastrointestinal disease, or be experiencing symptoms of dysphagia or recurrent vomiting that cause difficulty eating or taking medication.
- Participants with poorly controlled severe systemic diseases at screening, including, but not limited to, severe hypertension (SBP≥180 mmHg and/or DBP110 mmHg), severe cardiac disease, pulmonary disease, hepatic disease or haematological disorders, which significantly increase the participant's safety risk as assessed by the investigator;
- Participants with a history of tuberculosis, or who have current symptoms, signs, imaging or laboratory evidence of active tuberculosis, or who have a positive IGRA tuberculosis infection screening test result (except the participants who have medical documented evidence of having received standardized preventive anti-tuberculosis treatment within the 5 years prior to screening);
- ALT or AST or total bilirubin levels>3×ULN at screening;
- Hb<90 g/L or PLT<80×109/L at screening;
- HBsAg positive; or HBsAg negative but HBcAb positive with HBV-DNA quantitative results exceeding the ULN defined by the local lab; HCV antibody positive with HCV-RNA quantitative results exceeding the ULN defined by the local lab; HIV antibody positive;
- HBA1C≥9.0% at screening;
- Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or in any drug clinical trial within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening, or who participated in a clinical trial of oligonucleotide drugs within 1 year prior to randomization;
- Women who are pregnant or breastfeeding prior to randomization;
- Drug or alcohol abuse within 6 months prior to randomization;
- Any illness or condition that the investigator deems likely to increase the risk of the trial, affect participants adherence to the protocol or prevent them from completing it.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dr. Liang, +86 010-64008229, jgbgs090101@126.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy
This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.
Read the detailed description
This is a Phase 2, randomized, double-blind, parallel, placebo-controlled study in patients aged 18 years or above with biopsy confirmed diagnosis of IgA nephropathy. The clinical trial is designed to test the effectiveness and safety of multiple doses of HS-10542. The main objectives is to evaluate the dose response of different doses of HS-10542 by measuring urine protein-to-creatinine ratio (UPCR).
The trial is comprised of three main periods, Screening, Treatment (24 weeks) and Follow-Up (4 weeks). Approximately 90 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of HS-10542.
- Being tested
- HS-10542 High Dose, HS-10542 Low Dose, Placebo
- Keywords
- IgAN, Immunoglobulin A Nephropathy, HS-10542
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10542 High DoseDrug
Drug: HS-10542 High Dose, QD
HS-10542 Low DoseDrug
Drug: HS-10542 Low Dose, QD
PlaceboDrug
Placebo, QD
| Study group | Role | What they receive |
|---|---|---|
| HS-10542 High Dose Arm | Experimental | Experimental: HS-10542 High Dose, QD Receives: Drug: HS-10542 High Dose |
| HS-10542 Low Dose Arm | Experimental | Experimental: HS-10542 Low Dose, QD Receives: Drug: HS-10542 Low Dose |
| Placebo Arm | Placebo comparator | Placebo Comparator: Placebo，QD Receives: Drug: Placebo |
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)
The change of UPCR from baseline
Measured: Baseline and Week 12
Secondary outcomes (17)
Incidence and severity of adverse events of HS-10542 at each dosing
Measured: Baseline to End of Study (week 24)
Changes from baseline in blood pressures
Blood pressure measured during vital sign assessments
Measured: Baseline to End of Study (week 24)
Changes from baseline in heart rate
Heart rate measured during vital sign assessments
Measured: Baseline to End of Study (week 24)
Changes from baseline in body temperature
Body temperature measured during vital sign assessments.
Measured: Baseline to End of Study (week 24)
Changes from baseline in electrocardiogram (ECG) intervals
ECG intervals, and overall assessment will be recorded, includeing heart rate, PR, QRS, and QT(QTcF) intervals. QTcF will be calculated using Fridericia's formula: QTcF=QT/(RR⁰·³³), where RR is the standardized heart rate value derived as 60 / heart rate.
Measured: Baseline to End of Study (week 24)
Change from baseline in white blood cell count
Measured: Baseline to End of Study (week 24)
Change from baseline in hemoglobin
Measured: Baseline to End of Study (week 24)
Change from baseline in platelet count
Measured: Baseline to End of Study (week 24)
Change from baseline in alanine aminotransferase
Measured: Baseline to End of Study (week 24)
Change from baseline in aspartate aminotransferase
Measured: Baseline to End of Study (week 24)
Change from baseline in total bilirubin
Measured: Baseline to End of Study (week 24)
Change from baseline in serum creatinine
Measured: Baseline to End of Study (week 24)
Change from baseline in urinary erythrocyte count
Urinary erythrocyte count assessed by microscopic examination of urine sediment
Measured: Baseline to End of Study (week 24)
Change from baseline in prothrombin time
Measured: Baseline to End of Study (week 24)
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection)
The change of UPCR from baseline
Measured: Baseline and week 24
Change from baseline in estimated Glomerular Filtration Rate(eGFR)
Change from baseline in eGFR at treatment
Measured: Baseline to End of Study (week 24)
Change from baseline in activated partial thromboplastin time
Measured: Baseline to End of Study (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start17 Mar 2026 (estimated)
- Primary completion10 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgANStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474636
- Sponsor's protocol ID
- HS-10542-202
- Acronym
- HS-10542
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy
- ClinicalTrials.gov ID
- NCT07474636
- Acronym / sponsor ID
- HS-10542 / HS-10542-202
- Keywords
- IgAN, Immunoglobulin A Nephropathy, HS-10542
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (estimated)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 16 Mar 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.
This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.
Detailed description
This is a Phase 2, randomized, double-blind, parallel, placebo-controlled study in patients aged 18 years or above with biopsy confirmed diagnosis of IgA nephropathy. The clinical trial is designed to test the effectiveness and safety of multiple doses of HS-10542. The main objectives is to evaluate the dose response of different doses of HS-10542 by measuring urine protein-to-creatinine ratio (UPCR).
The trial is comprised of three main periods, Screening, Treatment (24 weeks) and Follow-Up (4 weeks). Approximately 90 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of HS-10542.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS-10542 High Dose Arm | Experimental | Drug: HS-10542 High DoseExperimental: HS-10542 High Dose, QD |
| HS-10542 Low Dose Arm | Experimental | Drug: HS-10542 Low DoseExperimental: HS-10542 Low Dose, QD |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo Comparator: Placebo，QD |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.
- Body weight≥35kg, BMI<37.5kg/m2.
- Primary IgA nephropathy was confirmed by renal biopsy within 8 years.
- 24-hour urine protein excretion≥1.0g/24h, or UPCR≥0.8g/g at screening and prior to randomization.
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization；
Key exclusion criteria (23 listed)
- Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
- Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria>3.5 g/day and serum albumin<3.0 g/dL, with or without edema);
- IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
- Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);
- Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.
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 |
|---|---|---|
| HS-10542 High DoseDrug: HS-10542 High Dose, QD | Drug | HS-10542 High Dose Arm |
| HS-10542 Low DoseDrug: HS-10542 Low Dose, QD | Drug | HS-10542 Low Dose Arm |
| PlaceboPlacebo, QD | Drug | Placebo Arm |
Primary outcome
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection)
Time frame: Baseline and Week 12
The change of UPCR from baseline
17 secondary outcomes
Incidence and severity of adverse events of HS-10542 at each dosing
Time frame: Baseline to End of Study (week 24)
Changes from baseline in blood pressures
Time frame: Baseline to End of Study (week 24)
Changes from baseline in heart rate
Time frame: Baseline to End of Study (week 24)
Changes from baseline in body temperature
Time frame: Baseline to End of Study (week 24)
Changes from baseline in electrocardiogram (ECG) intervals
Time frame: Baseline to End of Study (week 24)
Change from baseline in white blood cell count
Time frame: Baseline to End of Study (week 24)
Change from baseline in hemoglobin
Time frame: Baseline to End of Study (week 24)
Change from baseline in platelet count
Time frame: Baseline to End of Study (week 24)
Change from baseline in alanine aminotransferase
Time frame: Baseline to End of Study (week 24)
Change from baseline in aspartate aminotransferase
Time frame: Baseline to End of Study (week 24)
Change from baseline in total bilirubin
Time frame: Baseline to End of Study (week 24)
Change from baseline in serum creatinine
Time frame: Baseline to End of Study (week 24)
Change from baseline in urinary erythrocyte count
Time frame: Baseline to End of Study (week 24)
Change from baseline in prothrombin time
Time frame: Baseline to End of Study (week 24)
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection)
Time frame: Baseline and week 24
Change from baseline in estimated Glomerular Filtration Rate(eGFR)
Time frame: Baseline to End of Study (week 24)
Change from baseline in activated partial thromboplastin time
Time frame: Baseline to End of Study (week 24)
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 16 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-10542 High Dose and HS-10542 Low Dose in people with IgAN and Immunoglobulin A Nephropathy (IgAN), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 9 inclusion and 23 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Director Zhang (+86 010-83575530, hongzh@bjmu.edu.cn), 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) (time frame: Baseline and Week 12). 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 16 Mar 2026.