Primary IgA NephropathyPhase 3NCT07014826
A Trial of HRS-5965 Capsule in Primary IgA Nephropathy
A Phase 3 study testing HRS-5965 in people with Primary IgA Nephropathy, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to Dec 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
- Able and willing to provide a written informed consent；
- Weight ≥35 kg, Body mass index (BMI) < 37.5kg /m2;
- Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
- 24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
- A fertile female subject or a male subject whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan from the signing of the informed consent to 1 month after the last dose, and voluntarily takes effective contraceptive measures (including the partner);
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
- Receiving optimal supportive therapy including RAS blockers and stabilizing the dose for at least 12 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization;
Who cannot join
- Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
- Patients with secondary IgA nephropathy as determined by the investigator;
- 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 a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;
- Have any organ transplant;
- Patients with active infection of tuberculosis within 1 year prior to screening, such as liver abscess and pyelonephritis; Or subjects with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;
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- Patients with a history of malignant neoplasms;
- Patients 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;
- Patients 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;
- The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion;
- As determined by the investigator, the subject has any of the following: progression or recovery of a disease;
- Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) 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 who were within the follow-up period of a clinical study, or within 5 half-lives of the investigational drug, or within 30 days (whichever is older) before screening;
- Women who are pregnant or breastfeeding;
- A history of drug abuse;
- Participants who received systemic glucocorticoid or immune suppressants within 12 weeks prior to randomization and are expected to have during research；
- Participants who received biologics or cytokine inhibitor within 6 months prior to randomization and are expected to have during research；
- Any physical or mental illness or condition that, as determined by the investigator, is likely to increase the risk of the study, affect the subject's adherence to the protocol, or prevent the subject from completing the study.
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, 100034
Hong Zhang
About this study
Official title: Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Primary IgA Nephropathy
This multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.
- Conditions
- Primary IgA Nephropathy
- Being tested
- HRS-5965, 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.
HRS-5965Drug
HRS-5965
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | HRS-5965 Receives: Drug: HRS-5965 |
| Treatment group B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Measured: Baseline and Week 36
The total annualized slope of estimated glomerular filtration rate（eGFR）
Measured: Baseline and Week 104
Secondary outcomes (8)
The total annualized slope of estimated glomerular filtration rate（eGFR）
Measured: up to Week 36
Proportion of subjects with 24-hour urinary protein excretion (24-UPE) < 0.5 g/d and < 0.3 g/d
Measured: up to Week 36 and Week104
Proportion of subjects with 24-UPCR declined >50% to baseline
Measured: up to Week 36 and Week104
Ratio of 24-hour Urinary protein to creatinine ratio (24-UPCR) to baseline
Measured: up to Week 36 and Week104
Ratio of 24-hour Urinary protein to Albumin Creatinine ratio (24-UACR) to baseline
Measured: up to Week 36 and Week104
Ratio of 24-hour Urinary protein excretion（24-UPE） to baseline
Measured: up to Week 36 and Week104
Change from baseline of eGFR
Measured: up to Week 36 and Week104
Change from baseline of serum creatinine
Measured: up to Week 36 and Week104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start4 Jun 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2028 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 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
- NCT07014826
- Sponsor's protocol ID
- HRS-5965-305
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07014826
- Acronym / sponsor ID
- HRS-5965-305
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Jun 2025 (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 multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS-5965HRS-5965 |
| Treatment group B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to provide a written informed consent；
- Weight ≥35 kg, Body mass index (BMI) < 37.5kg /m2;
- Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
- 24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
Key exclusion criteria (18 listed)
- Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
- Patients with secondary IgA nephropathy as determined by the investigator;
- 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 a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;
- Have any organ transplant;
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-5965HRS-5965 | Drug | Treatment group A |
| PlaceboPlacebo | Drug | Treatment group B |
Primary outcome
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Time frame: Baseline and Week 36
The total annualized slope of estimated glomerular filtration rate（eGFR）
Time frame: Baseline and Week 104
8 secondary outcomes
The total annualized slope of estimated glomerular filtration rate（eGFR）
Time frame: up to Week 36
Proportion of subjects with 24-hour urinary protein excretion (24-UPE) < 0.5 g/d and < 0.3 g/d
Time frame: up to Week 36 and Week104
Proportion of subjects with 24-UPCR declined >50% to baseline
Time frame: up to Week 36 and Week104
Ratio of 24-hour Urinary protein to creatinine ratio (24-UPCR) to baseline
Time frame: up to Week 36 and Week104
Ratio of 24-hour Urinary protein to Albumin Creatinine ratio (24-UACR) to baseline
Time frame: up to Week 36 and Week104
Ratio of 24-hour Urinary protein excretion（24-UPE） to baseline
Time frame: up to Week 36 and Week104
Change from baseline of eGFR
Time frame: up to Week 36 and Week104
Change from baseline of serum creatinine
Time frame: up to Week 36 and Week104
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 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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 3 study testing HRS-5965 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 8 inclusion and 18 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 5 Aug 2025. 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 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 Sheng Qi (+86 0518 82342973, Sheng.qi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline (time frame: Baseline and 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 5 Aug 2025.