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To evaluate the safety and efficacy of Tai Ai(Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.
Both RC18 and Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection are other names of Tai Ai.
After a 35-day screen period, subjects are randomly allocated into 3 groups receiving subcutaneous injection of Tai Ai 160mg, Tai Ai 240mg, and placebo once a week individually. The treatment lasts 24 weeks. Subjects, the sponsor, investigators are blinded in the whole process of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC18 160mg | Experimental | RC18 160mg subcutaneous injection (S.C.) once weekly ,and a total of 24 doses |
|
| RC18 240mg | Experimental | RC18 240mg S.C. once weekly ,and a total of 24 doses |
|
| Placebo | Placebo Comparator | Placebo S.C. once weekly ,and a total of 24 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC18 160mg | Biological | subcutaneous injection on the upper arm, abdomen, or upper thigh outside; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour urine protein excretion at Week 24; | based on the 24 -hour urine collection | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in estimated Glomerular Filtration Rate(eGFR) | eGFR is calculated using the CKD-EPI method. | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in urine protein/creatine ratio(UPCR) and/or urine albumin/ creatine ratio(UACR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang, M.D. | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital. | Beijing | Beijing Municipality | 100010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41408192 | Derived | Pei J, Xu X, Huang R, Sun X, Zhang J, Chen X, Yao L, Zhang H, Shao L, Li Y. Efficacy and safety of low- to medium-dose telitacicept in adults with high-risk progressive IgA nephropathy: a retrospective real-world study. BMC Nephrol. 2025 Dec 17;27(1):92. doi: 10.1186/s12882-025-04708-w. | |
| 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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| ID | Term |
|---|---|
| C035529 | RC-18 |
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| RC18 240mg | Biological | subcutaneous injection on the upper arm, abdomen, or upper thigh outside; |
|
|
| placebo | Biological | subcutaneous injection on the upper arm, abdomen, or upper thigh outside; |
|
| week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in Immunoglobulin G(IgG); | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in Immunoglobulin M(IgM); | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in Immunoglobulin A(IgA); | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in the count of urine red blood cells | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in the count of B-lymphocytes (CD19+) | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in complement 3(C3) | week 0, 4, 8, 12, 16, 20, 24 |
| Change from baseline in complement 4 (C4) | week 0, 4, 8, 12, 16, 20, 24 |
| The incidence rate and severity of adverse events. | An adverse event is any undesirable experience associated with the use of a medical product in a patient. | week 0, 4, 8, 12, 16, 20, 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 |