Primary IgA NephropathyPhase 2NCT05847920
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
A Phase 2 study testing SHR-2010 Injection in people with Primary IgA Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary IgA Nephropathy
- What is being tested?
- SHR-2010 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2023to 20 Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Renal biopsy confirmed primary IgA nephropathy
- 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
- eGFR≥30 mL/min/ 1.73m2
- 40kg≤ Weight ≤100kg
- Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).
Who cannot join
- systemic disease which may cause secondary IgA deposition in the mesangial region
- Specific type of IgA nephropathy
- History of severe opportunistic infection
- A history of chronic or recurrent infection within 1 year prior to screening
- History of active digestive system within one year
- Have a malignant tumor or a history of malignant tumor
Show all 11Show fewer
- Subjects who have received organ transplants
- Associated with other serious or poorly controlled systemic diseases
- Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
- Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
- Received any systemic glucocorticoid 8 weeks before screening or during run-in period
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
About this study
Official title: A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy
The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.
- Conditions
- Primary IgA Nephropathy
- Being tested
- SHR-2010 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-2010 InjectionDrug
SHR-2010 Injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR-2010 Injection | Experimental | Not described Receives: Drug: SHR-2010 Injection |
| 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.
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
Measured: 12 weeks
Part 2: change from baseline in UPCR at 24weeks.
Measured: 24 weeks
Secondary outcomes (6)
change from baseline in 24 hours urinary protein at 12 weeks (part 1)
Measured: 12 weeks
change from baseline in 24 hours urinary protein at 24 weeks (part 2)
Measured: 24 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）
Measured: 12 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.
Measured: 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.
Measured: 12, 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.
Measured: 24, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start4 Jun 2023
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.
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.
- 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
- 53 participants (actual)
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
- NCT05847920
- Sponsor's protocol ID
- SHR-2010-201
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2023
- Last updated
- 5 Mar 2025
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT05847920
- Acronym / sponsor ID
- SHR-2010-201
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 8 May 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 SHR - 2010 injection in patients with 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 |
|---|---|---|
| SHR-2010 Injection | Experimental | Drug: SHR-2010 Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to provide a written informed consent
- Renal biopsy confirmed primary IgA nephropathy
- 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
- eGFR≥30 mL/min/ 1.73m2
- 40kg≤ Weight ≤100kg
Key exclusion criteria (11 listed)
- systemic disease which may cause secondary IgA deposition in the mesangial region
- Specific type of IgA nephropathy
- History of severe opportunistic infection
- A history of chronic or recurrent infection within 1 year prior to screening
- History of active digestive system within one year
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-2010 InjectionSHR-2010 Injection | Drug | SHR-2010 Injection |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
Time frame: 12 weeks
Part 2: change from baseline in UPCR at 24weeks.
Time frame: 24 weeks
6 secondary outcomes
change from baseline in 24 hours urinary protein at 12 weeks (part 1)
Time frame: 12 weeks
change from baseline in 24 hours urinary protein at 24 weeks (part 2)
Time frame: 24 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）
Time frame: 12 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.
Time frame: 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.
Time frame: 12, 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.
Time frame: 24, 36 weeks
Results and safety
The study was stopped early (reason given: Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- 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 SHR-2010 Injection in people with Primary IgA Nephropathy, run by Guangdong Hengrui Pharmaceutical 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 11 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: stopped early, as of the sponsor's last update on 5 Mar 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 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 was stopped early (reason given: Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.). Results are not available in the source record.
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?
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks. (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT05847920, 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 5 Mar 2025.