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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-2173 injection | Experimental |
| |
| Treatment group B: SHR-2173 injection | Experimental |
| |
| Treatment group C: SHR-2173 injection | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 injection | Drug | SHR-2173 injection;High dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24. | Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour UPCR ; | up to Week 48 | |
| Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ; | up to Week 48 | |
| Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ; |
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Inclusion Criteria:
Exclusion Criteria:
-
1、Presence of any of the following medical histories or comorbidities:
2、Use of any of the following drugs/treatments or participation in a clinical study:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kunming Li | Contact | 0518-82342973 | kunming.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| SHR-2173 injection |
| Drug |
SHR-2173 injection;Medium dose |
|
| SHR-2173 injection | Drug | SHR-2173 injection;Low dose |
|
| Placebo | Drug | Placebo |
|
| up to Week 48 |
| Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ; | up to Week 48 |
| Change from baseline in 24-hour urinary protein quantification ; | up to Week 48 |
| Change from baseline in estimated Glomerular Filtration Rate (eGFR) ; | up to Week 48 |
| Change from baseline in hematuria ; | up to Week 48 |
| Change from baseline in serum creatinine ; | up to Week 48 |
| Proportion of participants achieving clinical remission; | up to Week 48 |
| Annualized total eGFR slope from baseline ; | up to Week 48 |
| Proportion of participants meeting composite endpoints ; | up to Week 48 |
| Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ; | up to Week 48 |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |