IgA NephropathyPhase 2NCT05016323
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
A Phase 2 study testing HR19042 Capsules in people with IgA Nephropathy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- HR19042 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2021to 15 Aug 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
- Female or male patients ≥18 years old；
- Biopsy-confirmed primary IgA nephropathy；
- Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
- Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
- Willing and able to take adequate contraception during the trial;
- Willing and able to give informed consent and follow the protocols during the trial.
Who cannot join
- Systemic diseases which could lead to secondary IgA nephropathy；
- Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
- Patients with severe cardiovascular diseases；
- Patients diagnosed with malignancy within the past 5 years；
- Patients with liver cirrhosis；
- Patients received organ transplantation；
Show all 10Show fewer
- Patients with uncontrolled Type 1 or 2 diabetes；
- Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
- Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening；
- Patients treated with any systemic corticosteroids within the past 3 months before screening.
Trial locations and contacts
1 site in 1 country.
China1 site
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.
- Conditions
- IgA Nephropathy
- Being tested
- HR19042 Capsules, 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.
HR19042 CapsulesDrug
HR19042 Capsules
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HR19042 Capsules | Experimental | Not described Receives: Drug: HR19042 Capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urine protein creatinine ratio (UPCR)
Measured: 9 months
Secondary outcomes (4)
Change from baseline in 24-hour proteinuria
Measured: 9 months
Change from baseline in urine albumin creatinine ratio (UACR)
Measured: 9 months
Change from baseline in estimated GFR
Measured: 9 months
Change from baseline in estimated GFR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start9 Sep 2021
- Primary completion9 Jun 2024
- Study completion15 Aug 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 IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Model description
- A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016323
- Sponsor's protocol ID
- HR19042-201
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2021
- Last updated
- 12 Mar 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
- ClinicalTrials.gov ID
- NCT05016323
- Acronym / sponsor ID
- HR19042-201
- Conditions
- IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 9 Jun 2024 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 23 Aug 2021 (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 HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial
| Arm | Type | Receives |
|---|---|---|
| HR19042 Capsules | Experimental | Drug: HR19042 Capsules |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male patients ≥18 years old；
- Biopsy-confirmed primary IgA nephropathy；
- Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
- Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
- Willing and able to take adequate contraception during the trial;
Key exclusion criteria (10 listed)
- Systemic diseases which could lead to secondary IgA nephropathy；
- Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
- Patients with severe cardiovascular diseases；
- Patients diagnosed with malignancy within the past 5 years；
- Patients with liver cirrhosis；
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 |
|---|---|---|
| HR19042 CapsulesHR19042 Capsules | Drug | HR19042 Capsules |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline in urine protein creatinine ratio (UPCR)
Time frame: 9 months
4 secondary outcomes
Change from baseline in 24-hour proteinuria
Time frame: 9 months
Change from baseline in urine albumin creatinine ratio (UACR)
Time frame: 9 months
Change from baseline in estimated GFR
Time frame: 9 months
Change from baseline in estimated GFR
Time frame: 12 months
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 12 Mar 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 HR19042 Capsules in people with IgA Nephropathy, run by Jiangsu HengRui 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 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: finished, as of the sponsor's last update on 12 Mar 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?
Change from baseline in urine protein creatinine ratio (UPCR) (time frame: 9 months). 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 NCT05016323, 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 12 Mar 2026.