Immunoglobulin a NephropathyPhase 2NCT06635772
A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy
A Phase 2 study testing HS-10390 and Irbesartan in people with Immunoglobulin a Nephropathy, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immunoglobulin a Nephropathy
- 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
- 90 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to 30 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 65 years age.
- Biopsy-proven primary IgA nephropathy.
- Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
- Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
- Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m^2 at screening.
- Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.
Who cannot join
- IgA nephropathy secondary to another condition
- 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%;
- Chronic kidney disease (CKD) in addition to IgAN
- Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
- Require any prohibited medications prior to randomizing;
- Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
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- History of organ transplantation, with exception of corneal transplants
- Platelet< 100×109/L or hemoglobin value < 90 g/L) or Hematocrit value < 27% (0.27 V/V) at Screening
- Elevations of transaminases (ALT and/or AST) >2 times upper limit of normal or total bilirubin and/or direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening
- Potassium >5.5 mmol/L at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy
This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.
- Conditions
- Immunoglobulin a Nephropathy
- Being tested
- HS-10390, Irbesartan
- Keywords
- Immunoglobulin A Nephropathy
- 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-10390Drug
HS-10390 will be administered daily
IrbesartanDrug
Irbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg
| Study group | Role | What they receive |
|---|---|---|
| HS-10390; high dose | Experimental | HS-10390; high dose Receives: Drug: HS-10390 |
| HS-10390; low dose | Experimental | HS-10390; low dose Receives: Drug: HS-10390 |
| irbesartan | Active comparator | Irbesartan will be administered daily as a 150-mg oral tablet. 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 from baseline in 24-hour urine protein at Week 12
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
Measured: up to week 12
Secondary outcomes (7)
Change from baseline in 24-hour urine protein (UPCR)
The change in urine protein: creatinine ratio (UPCR) from baseline
Measured: up to Week 12
Change from baseline in 24-hour urine protein(UACR)
The change in urine albumin: creatinine ratio (UACR) from baseline
Measured: up to Week 12
Change from baseline in 24-hour urine protein
The change in urine protein excretion from baseline
Measured: up to Week 12
Proportion Change from baseline in 24-hour urine protein
The proportion of patients with urinary protein equivalent of < 0.3 g/24 hours
Measured: up to Week 12
change from baseline in Estimated Glomerular Filtration Rate
change from baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: up to Week 12
Number of subjects with adverse events (AEs)
Type, incidence, severity, seriousness, and relatedness of AEs will be collected
Measured: up to Week 12
Plasma Concentration of HS-10390
Blood samples will be collected for the measurement of plasma concentrations of HS-10390
Measured: up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study startNov 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin a NephropathyStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635772
- Sponsor's protocol ID
- HS-10390-201
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy
- ClinicalTrials.gov ID
- NCT06635772
- Acronym / sponsor ID
- HS-10390-201
- Conditions
- Immunoglobulin a Nephropathy
- Keywords
- Immunoglobulin A Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 10 Oct 2024 (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 study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS-10390; high dose | Experimental | Drug: HS-10390HS-10390; high dose |
| HS-10390; low dose | Experimental | Drug: HS-10390HS-10390; low dose |
| irbesartan | Active comparator | Drug: IrbesartanIrbesartan will be administered daily as a 150-mg oral tablet. 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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, between 18 and 65 years age.
- Biopsy-proven primary IgA nephropathy.
- Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
- Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
- Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m^2 at screening.
Key exclusion criteria (10 listed)
- IgA nephropathy secondary to another condition
- 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%;
- Chronic kidney disease (CKD) in addition to IgAN
- Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
- Require any prohibited medications prior to randomizing;
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 will be administered daily | Drug | HS-10390; high dose, HS-10390; low dose |
| IrbesartanIrbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg | Drug | irbesartan |
Primary outcome
Change from baseline in 24-hour urine protein at Week 12
Time frame: up to week 12
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
7 secondary outcomes
Change from baseline in 24-hour urine protein (UPCR)
Time frame: up to Week 12
Change from baseline in 24-hour urine protein(UACR)
Time frame: up to Week 12
Change from baseline in 24-hour urine protein
Time frame: up to Week 12
Proportion Change from baseline in 24-hour urine protein
Time frame: up to Week 12
change from baseline in Estimated Glomerular Filtration Rate
Time frame: up to Week 12
Number of subjects with adverse events (AEs)
Time frame: up to Week 12
Plasma Concentration of HS-10390
Time frame: up to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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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. This study is not recruiting at the moment.
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 Immunoglobulin a Nephropathy, run by Hansoh BioMedical R&D Company 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jicheng Lv, PhD (+8613161753111, chenglv@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24-hour urine protein at Week 12 (time frame: up to 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 10 Oct 2024.