Primary IgA NephropathyPhase 2NCT07354932
A Study of SHR-2173 in Participants With Primary IgA Nephropathy
A Phase 2 study testing SHR-2173 injection in people with Primary IgA Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. 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?
- SHR-2173 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 9 Mar 2026to Dec 2027
- 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
- Male and female participants aged 18 or older
- Body weight ≥35 kg, BMI<37.5 kg/m2
- At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
- eGFR≥30 mL/ minute /1.73 m2 at screening
- Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol
Who cannot join
- -
- 1、Presence of any of the following medical histories or comorbidities:
- Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;
- A history of organ transplantation;
- A history of splenectomy;
- Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);
Show all 19Show fewer
- A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug
- 2、Use of any of the following drugs/treatments or participation in a clinical study:
- Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);
- Receivied immunosuppressive therapy within 12 weeks before randomization;
- Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;
- Received a live / attenuated live vaccine administered within 4 weeks before randomization
- 3、History and examination related to infection:
- A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization;
- Tuberculosis (TB) or occult TB infection (one of the following conditions) :
- Presence of active TB or clinical symptoms of active TB at screening;
- Signs of active TB on imaging examination within 3 months before screening
- 4、 General situation:
- 1) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Chen
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jingyuan Xie
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.
- Conditions
- Primary IgA Nephropathy
- Being tested
- SHR-2173 injection, 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.
SHR-2173 injectionDrug
SHR-2173 injection；High dose
SHR-2173 injectionDrug
SHR-2173 injection；Medium dose
SHR-2173 injectionDrug
SHR-2173 injection；Low dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-2173 injection | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Treatment group B: SHR-2173 injection | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Treatment group C: SHR-2173 injection | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Placebo Group | 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 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.
Measured: Week 24.
Secondary outcomes (12)
Change from baseline in 24-hour UPCR ;
Measured: up to Week 48
Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;
Measured: up to Week 48
Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;
Measured: up to Week 48
Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;
Measured: up to Week 48
Change from baseline in 24-hour urinary protein quantification ;
Measured: up to Week 48
Change from baseline in estimated Glomerular Filtration Rate (eGFR) ;
Measured: up to Week 48
Change from baseline in hematuria ;
Measured: up to Week 48
Change from baseline in serum creatinine ;
Measured: up to Week 48
Proportion of participants achieving clinical remission;
Measured: up to Week 48
Annualized total eGFR slope from baseline ;
Measured: up to Week 48
Proportion of participants meeting composite endpoints ;
Measured: up to Week 48
Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ;
Measured: up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (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.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354932
- Sponsor's protocol ID
- SHR-2173-205
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07354932
- Acronym / sponsor ID
- SHR-2173-205
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jan 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 is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR-2173 injection | Experimental | Drug: SHR-2173 injection |
| Treatment group B: SHR-2173 injection | Experimental | Drug: SHR-2173 injection |
| Treatment group C: SHR-2173 injection | Experimental | Drug: SHR-2173 injection |
| Placebo Group | 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 (5 listed)
- Male and female participants aged 18 or older
- Body weight ≥35 kg, BMI<37.5 kg/m2
- At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
- eGFR≥30 mL/ minute /1.73 m2 at screening
- Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol
Key exclusion criteria (19 listed)
- -
- Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;
- A history of organ transplantation;
- A history of splenectomy;
- Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);
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 |
|---|---|---|
| SHR-2173 injectionSHR-2173 injection；High dose | Drug | Treatment group A: SHR-2173 injection |
| SHR-2173 injectionSHR-2173 injection；Medium dose | Drug | Treatment group B: SHR-2173 injection |
| SHR-2173 injectionSHR-2173 injection；Low dose | Drug | Treatment group C: SHR-2173 injection |
| PlaceboPlacebo | Drug | Placebo Group |
Primary outcome
Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.
Time frame: Week 24.
12 secondary outcomes
Change from baseline in 24-hour UPCR ;
Time frame: up to Week 48
Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;
Time frame: up to Week 48
Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;
Time frame: up to Week 48
Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;
Time frame: up to Week 48
Change from baseline in 24-hour urinary protein quantification ;
Time frame: up to Week 48
Change from baseline in estimated Glomerular Filtration Rate (eGFR) ;
Time frame: up to Week 48
Change from baseline in hematuria ;
Time frame: up to Week 48
Change from baseline in serum creatinine ;
Time frame: up to Week 48
Proportion of participants achieving clinical remission;
Time frame: up to Week 48
Annualized total eGFR slope from baseline ;
Time frame: up to Week 48
Proportion of participants meeting composite endpoints ;
Time frame: up to Week 48
Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ;
Time frame: up to Week 48
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 13 May 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-2173 injection in people with Primary IgA Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites 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 5 inclusion and 19 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Kunming Li (0518-82342973, kunming.li@hengrui.com), 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-to-Creatinine Ratio (UPCR) at Week 24. (time frame: Week 24.). 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 13 May 2026.