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Based on the adjustment of the R & D strategy, the sponsor decides to terminate the research.
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The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2010 Injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2010 Injection | Drug | SHR-2010 Injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks. | 12 weeks | |
| Part 2: change from baseline in UPCR at 24weeks. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in 24 hours urinary protein at 12 weeks (part 1) | 12 weeks | |
| change from baseline in 24 hours urinary protein at 24 weeks (part 2) | 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Eastern Theater Command | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38299639 | Derived | 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. |
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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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| Drug |
Placebo |
|
| change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks(Part 1) |
| 12 weeks |
| change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks(Part 2). | 24 weeks |
| change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks (Part 1). | 12, 24 weeks |
| change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks (Part 2). | 24, 36 weeks |
| 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 |