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The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blisibimod | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blisibimod | Drug | Blisibimod administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects to achieve the proteinuria threshold | Week 24 | |
| The proportion of subjects who progress to end-stage renal disease | approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets | Week 24 | |
| Number of Participants with Adverse Events | Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| C573858 | AMG623 peptibody |
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| Placebo |
| Drug |
Placebo administered subcutaneously |
|
| Change from baseline in serum creatinine |
| Week 24 |
| Change from baseline in eGFR | Week 24 |
| The proportion of subjects requiring the addition of corticosteroid or other therapy | 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 |