Chronic Kidney DiseasePhase 2NCT07555054
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease
A Phase 2 study testing HS-10390 and Irbesartan in people with Chronic Kidney Disease, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- HS-10390 and Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-70 years old;
- Body mass index (BMI) ≥18.0 and <50.0 kg/m^2 at screening;
- Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;
- Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m^2 calculated using the 2021 CKD-EPI creatine formula at screening;
- Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
- Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
- Agree to contraception.
Who cannot join
- A known or suspected allergy to the investigational medical drug or its components or excipients;
- Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
- If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
- Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
- Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
- Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
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- Acute kidney injury or dialysis treatment within 6 months before screening;
- Received kidney transplant, or plan to receive kidney transplant during the trial;
- Platelet< 100×10^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
- Elevations of transaminases (ALT and/or AST) >3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;
- Serum potassium >5.5 mmol/L at screening.
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
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong
Wei Chen WC archiater, Doctor, 13924150966, Emailwchen66@qq.com
About this study
Official title: A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease
The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g
- Conditions
- Chronic Kidney Disease
- Being tested
- HS-10390, Irbesartan
- Keywords
- chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10390Drug
HS-10390
HS-10390Drug
HS-10390
HS-10390Drug
HS-10390
IrbesartanDrug
Target dose of 300 mg daily
| Study group | Role | What they receive |
|---|---|---|
| HS-10390 Dose A | Experimental | HS-10390 Dose A Receives: Drug: HS-10390 |
| HS-10390 Dose B | Experimental | HS-10390 Dose B Receives: Drug: HS-10390 |
| HS-10390 Dose C | Experimental | HS-10390 Dose C Receives: Drug: HS-10390 |
| Irbesartan | Active comparator | Irbesartan will be administered daily as a 150-mg oral tablet. Irbesartan will be administered daily as a 150-mg orally for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg. Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
Measured: Frame: From baseline (Day 1) until Week 12 (Day 85)
Secondary outcomes (6)
Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12
Measured: From baseline (Day 1) until Week 12 (Day 85)
Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit
Measured: From baseline (Day 1) at each visit
Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit
Measured: From baseline (Day 1) at Each Visit
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit
Measured: From baseline (Day 1) at Each Visit
Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit
Measured: From baseline (Day 1) at Each Visit
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: From screening until Follow-up visit (Day 98)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start21 May 2026 (estimated)
- Primary completion11 Nov 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 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
- NCT07555054
- Sponsor's protocol ID
- HS-10390-202
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07555054
- Acronym / sponsor ID
- HS-10390-202
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (estimated)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Apr 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.
The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-10390 Dose A | Experimental | Drug: HS-10390HS-10390 Dose A |
| HS-10390 Dose B | Experimental | Drug: HS-10390HS-10390 Dose B |
| HS-10390 Dose C | Experimental | Drug: HS-10390HS-10390 Dose C |
| Irbesartan | Active comparator | Drug: IrbesartanIrbesartan will be administered daily as a 150-mg oral tablet. Irbesartan will be administered daily as a 150-mg orally for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 18-70 years old;
- Body mass index (BMI) ≥18.0 and <50.0 kg/m^2 at screening;
- Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;
- Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m^2 calculated using the 2021 CKD-EPI creatine formula at screening;
- Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
Key exclusion criteria (11 listed)
- A known or suspected allergy to the investigational medical drug or its components or excipients;
- Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
- If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
- Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
- Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
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-10390HS-10390 | Drug | HS-10390 Dose A |
| HS-10390HS-10390 | Drug | HS-10390 Dose B |
| HS-10390HS-10390 | Drug | HS-10390 Dose C |
| IrbesartanTarget dose of 300 mg daily | Drug | Irbesartan |
Primary outcome
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
Time frame: Frame: From baseline (Day 1) until Week 12 (Day 85)
6 secondary outcomes
Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12
Time frame: From baseline (Day 1) until Week 12 (Day 85)
Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit
Time frame: From baseline (Day 1) at each visit
Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit
Time frame: From baseline (Day 1) at Each Visit
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit
Time frame: From baseline (Day 1) at Each Visit
Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit
Time frame: From baseline (Day 1) at Each Visit
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From screening until Follow-up visit (Day 98)
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 Apr 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-10390 and Irbesartan in people with Chronic Kidney Disease, 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 7 inclusion and 11 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 28 Apr 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. 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 Wei Chen Professor, MD (13924150966, Emailwchen66@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 (time frame: Frame: From baseline (Day 1) until Week 12 (Day 85)). 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 Apr 2026.