Primary IgA NephropathyPhase 2NCT06137768
A Trial of HRS-5965 Tablets in Primary IgA Nephropathy
A Phase 2 study testing HRS-5965 in people with Primary IgA Nephropathy, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HRS-5965 tablets for primary IgA nephropathy. To explore the effective dosage of HRS-5965 tablets 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
- 123 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2023to 17 Oct 2025
- 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 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 5 years;
- 24-UPE≥ 0.75g /24h, or UPCR≥ 0.8g/g at screening and 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);
- Receiving optimal supportive therapy including RAS blockers for 12 weeks and stabilizing the dose for at least 4 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;
- Have any organ transplant;
- Patients with chronic recurrent infections 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;
- 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.
China1 site
Beijing University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Trial to Evaluate the Efficacy and Safety of HRS-5965 Tablets in Primary IgA Nephropathy
The study is being conducted to evaluate the efficacy, and safety of HRS-5965 tablets for primary IgA nephropathy. To explore the effective dosage of HRS-5965 tablets 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: HRS-5965; high dose | Experimental | Not described Receives: Drug: HRS-5965 |
| Treatment group B: HRS-5965; medium dose | Experimental | Not described Receives: Drug: HRS-5965 |
| Treatment group C: HRS-5965; low dose | Experimental | Not described Receives: Drug: HRS-5965 |
| Treatment group D: Placebo. | Placebo comparator | Not described Receives: Drug: Placebo |
| Treatment group E | Experimental | Not described Receives: Drug: HRS-5965 |
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 12
Secondary outcomes (6)
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Measured: Baseline and Week 24
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Measured: up to Week 24
Ratio of 24-hour Urinary protein excretion（UPE） to baseline
Measured: up to Week 24
Change from baseline of estimated glomerular filtration rate（eGFR）
Measured: up to Week 24
Change from baseline of serum creatinine
Measured: up to Week 24
Ratio of Urinary protein to creatinine ratio and Urinary albumin to creatinine ratio to baseline
Measured: up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Dec 2023
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
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
- NCT06137768
- Sponsor's protocol ID
- HRS-5965-201
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PubMed 38299639
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate the Efficacy and Safety of HRS-5965 Tablets in Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06137768
- Acronym / sponsor ID
- HRS-5965-201
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 18 Nov 2023 (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 study is being conducted to evaluate the efficacy, and safety of HRS-5965 tablets for primary IgA nephropathy. To explore the effective dosage of HRS-5965 tablets 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-5965; high dose | Experimental | Drug: HRS-5965 |
| Treatment group B: HRS-5965; medium dose | Experimental | Drug: HRS-5965 |
| Treatment group C: HRS-5965; low dose | Experimental | Drug: HRS-5965 |
| Treatment group D: Placebo. | Placebo comparator | Drug: Placebo |
| Treatment group E | Experimental | Drug: HRS-5965 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 5 years;
- 24-UPE≥ 0.75g /24h, or UPCR≥ 0.8g/g at screening and prior to randomization;
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
Key exclusion criteria (16 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;
- 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: HRS-5965; high dose, Treatment group B: HRS-5965; medium dose, Treatment group C: HRS-5965; low dose, Treatment group E |
| PlaceboPlacebo. | Drug | Treatment group D: Placebo. |
Primary outcome
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Time frame: Baseline and Week 12
6 secondary outcomes
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Time frame: Baseline and Week 24
Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline
Time frame: up to Week 24
Ratio of 24-hour Urinary protein excretion（UPE） to baseline
Time frame: up to Week 24
Change from baseline of estimated glomerular filtration rate（eGFR）
Time frame: up to Week 24
Change from baseline of serum creatinine
Time frame: up to Week 24
Ratio of Urinary protein to creatinine ratio and Urinary albumin to creatinine ratio to baseline
Time frame: up to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 38299639Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 24 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06137768, which also lists 1 linked publication.
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 24 Jul 2026.