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The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-1400 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-1400 | Drug | BHV-1400 is delivered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths | To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths | Up to 1 year |
| Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities | To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities. | Up to 1 year |
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Key Inclusion Criteria:
1. Participants must have biopsy-confirmed IgA Nephropathy
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Contact | 203-404-0410 | clinicaltrials@biohavenpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-001 | Recruiting | Farmington | Connecticut | 06030 | United States | |
| Site-003 |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D011507 | Proteinuria |
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D009393 | Nephritis |
| D014570 | Urologic Diseases |
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Recruiting |
| Miami Lakes |
| Florida |
| 33016 |
| United States |
| Site-011 | Recruiting | Miami Lakes | Florida | 33172 | United States |
| Site-013 | Recruiting | Orlando | Florida | 32806 | United States |
| Site-005 | Recruiting | Pembroke Pines | Florida | 33029 | United States |
| Site-008 | Recruiting | Lawrenceville | Georgia | 30046 | United States |
| Site-009 | Recruiting | Hinsdale | Illinois | 60521 | United States |
| Site-012 | Recruiting | Indianapolis | Indiana | 46268 | United States |
| Site-015 | Recruiting | Shelby | Michigan | 48316 | United States |
| Site-006 | Recruiting | Chesterfield | Missouri | 63017 | United States |
| Site-002 | Recruiting | Dakota Dunes | South Dakota | 57049 | United States |
| Site-014 | Recruiting | Houston | Texas | 77027 | United States |
| Site-004 | Recruiting | Houston | Texas | 77099 | United States |
| Site-016 | Recruiting | Salt Lake City | Utah | 84115 | United States |
| Site-007 | Recruiting | Leicester | LE5 4PW | United Kingdom |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |