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The study is being conducted to evaluate the efficacy, and safety of HRS-5965 tablets for primary IgA nephropathy. To explore the effective dosage of HRS-5965 tablets for primary IgA nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-5965; high dose | Experimental |
| |
| Treatment group B: HRS-5965; medium dose | Experimental |
| |
| Treatment group C: HRS-5965; low dose | Experimental |
| |
| Treatment group D: Placebo. | Placebo Comparator |
| |
| Treatment group E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5965 | Drug | HRS-5965 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline | Baseline and Week 24 | |
| Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline | up to Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University First Hospital | Beijing | Beijing Municipality | 100034 | 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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| Placebo | Drug | Placebo. |
|
| Ratio of 24-hour Urinary protein excretion(UPE) to baseline |
| up to Week 24 |
| Change from baseline of estimated glomerular filtration rate(eGFR) | up to Week 24 |
| Change from baseline of serum creatinine | up to Week 24 |
| Ratio of Urinary protein to creatinine ratio and Urinary albumin to creatinine ratio to baseline | up to Week 24 |
| 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 |