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The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blisibimod | Experimental | Blisibimod administered subcutaneously |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blisibimod | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving reduction in proteinuria from baseline | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum immunoglobulins IgA, IgG and IgM | 24 weeks | |
| Percent reduction from baseline in plasma cells and B-cell subsets | 24 weeks | |
| Percent change from baseline in complement C3 and C4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 852 | Olomouc | Czechia | ||||
| Investigator 851 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26032537 | Derived | Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 10, 2018 | |
| Reset | Oct 18, 2018 |
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|
| 24 weeks |
| Proportion of subjects progressing to End Stage Renal Disease | Approximately 104 weeks |
| Proportion of subjects achieving reduction in proteinuria from baseline | Approximately 104 weeks |
| Numbers of subjects requiring the addition of corticosteroid or other therapy | 24 weeks |
| Prague |
| Czechia |
| Investigator Site 905 | Düsseldorf | 40210 | Germany |
| Investigator Site 101 | Hong Kong | Hong Kong |
| Investigator Site 603 | Kajang | 43000 | Malaysia |
| Investigator Site 402 | Quezon City | 1101 | Philippines |
| Investigator Site 401 | Quezon City | Philippines |
| Investigator Site 202 | Singapore | 169608 | Singapore |
| Investigator Site 201 | Singapore | 308433 | Singapore |
| Investigator Site 305 | Busan | 612-896 | South Korea |
| Investigator Site 306 | Busan | 614-735 | South Korea |
| Investigator Site 303 | Daejeon | 301-721 | South Korea |
| Investigator Site 301 | Seoul | 110-744 | South Korea |
| Investigator Site 302 | Seoul | 137-701 | South Korea |
| Investigator Site 704 | Changhua | 500 | Taiwan |
| Investigator Site 705 | Tainan | 70428 | Taiwan |
| Investigator Site 504 | Bangkok | 10330 | Thailand |
| Investigator Site 505 | Bangkok | 10400 | Thailand |
| Investigator Site 503 | Bangkok | 10700 | Thailand |
| Investigator Site 501 | Chang Mai | 50200 | Thailand |
| Investigator Site 806 | Bradford | United Kingdom |
| Investigator Site 801 | Leicester | United Kingdom |
| Investigator Site 803 | London | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 10, 2018 | Oct 18, 2018 |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D014570 | Urologic Diseases |
| 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 |
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| ID | Term |
|---|---|
| C573858 | AMG623 peptibody |
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