Primary IgA NephropathyPhase 2NCT07582133
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy
A Phase 2 study testing HRS-5965 Capsules in people with Primary IgA Nephropathy, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary IgA Nephropathy
- What is being tested?
- HRS-5965 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2026to Nov 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;
- Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.
Who cannot join
- Hypersensitivity to the study drug or its components；
- History of immunodeficiency disorders；
- History of invasive encapsulated bacterial infection；
- History of malignant neoplasm；
- The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2；
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, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Hong Zhang
About this study
Official title: A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules in Patients With Primary IgA Nephropathy
This study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.
- Conditions
- Primary IgA Nephropathy
- Being tested
- HRS-5965 Capsules
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5965 CapsulesDrug
HRS-5965 Capsules
| Study group | Role | What they receive |
|---|---|---|
| HRS-5965 Capsules | Experimental | Not described Receives: Drug: HRS-5965 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events (AEs) throughout the study;
Measured: 2 years
Secondary outcomes (5)
Ratio of 24-hour urine protein excretion (24-UPE) to baseline;
Measured: 2 years
The change from baseline in estimated glomerular filtration rate (eGFR);
Measured: 2 years
The change from baseline in serum creatinine (Scr);
Measured: 2 years
The proportion of participants with 24-UPE < 0.5 g/d;
Measured: 2 years
The proportion of participants with 24-UPE < 0.3 g/d;
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start6 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary IgA NephropathyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582133
- Sponsor's protocol ID
- HRS-5965-206
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules in Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07582133
- Acronym / sponsor ID
- HRS-5965-206
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 12 May 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 study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-5965 Capsules | Experimental | Drug: HRS-5965 Capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;
- Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.
Key exclusion criteria (5 listed)
- Hypersensitivity to the study drug or its components；
- History of immunodeficiency disorders；
- History of invasive encapsulated bacterial infection；
- History of malignant neoplasm；
- The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2；
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 |
|---|---|---|
| HRS-5965 CapsulesHRS-5965 Capsules | Drug | HRS-5965 Capsules |
Primary outcome
The incidence and severity of adverse events (AEs) throughout the study;
Time frame: 2 years
5 secondary outcomes
Ratio of 24-hour urine protein excretion (24-UPE) to baseline;
Time frame: 2 years
The change from baseline in estimated glomerular filtration rate (eGFR);
Time frame: 2 years
The change from baseline in serum creatinine (Scr);
Time frame: 2 years
The proportion of participants with 24-UPE < 0.5 g/d;
Time frame: 2 years
The proportion of participants with 24-UPE < 0.3 g/d;
Time frame: 2 years
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 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Primary IgA Nephropathy
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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
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A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
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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 HRS-5965 Capsules in people with Primary IgA Nephropathy, run by Chengdu Suncadia Medicine 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 2 inclusion and 5 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 22 Jul 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 Yanfang Zou (+0518-82342973, yanfang.zou@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (AEs) throughout the study; (time frame: 2 years). 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 22 Jul 2026.