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Study recruitment is paused due to business reasons, but not due to regulatory or safety concerns.
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The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atacicept Dose | Experimental | Atacicept Dose once weekly subcutaneous (SC) Injection |
|
| Placebo to match Atacicept | Placebo Comparator | Placebo to match Atacicept once weekly subcutaneous (SC) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atacicept | Drug | Once weekly subcutaneous (SC) injections by prefilled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20% | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Response with alternative success criteria | Weeks 52 and 104 | |
| Time to UPCR of≤0.5 mg/mg | Week 52 | |
| Renal Response at Week 104 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Curley | Chief Development Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vera Site # 0139 | Huntsville | Alabama | 35805 | United States | ||
| Vera Site # 0138 |
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| Label | URL |
|---|---|
| Vera Therapeutics, Inc. Company Website | View source |
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| Placebo | Drug | placebo |
|
| Week 104 |
| Time to Death or Renal-Related Event | Week 104 |
| La Jolla |
| California |
| 92037 |
| United States |
| Vera Site # 0127 | La Palma | California | 90623 | United States |
| Vera Site # 0129 | Long Beach | California | 90822 | United States |
| Vera Site # 0135 | Northridge | California | 91324 | United States |
| Vera Site # 0136 | Northridge | California | 91324 | United States |
| Vera Site # 0130 | Santa Clarita | California | 91321 | United States |
| Vera Site # 0131 | Torrance | California | 90502 | United States |
| Vera Site # 0143 | New Haven | Connecticut | 06520 | United States |
| Vera Site # 0140 | Gainesville | Florida | 32610 | United States |
| Vera Site # 0128 | Miami | Florida | 33125 | United States |
| Vera Site # 0134 | Atlanta | Georgia | 30309 | United States |
| Vera Site # 0137 | Augusta | Georgia | 30912 | United States |
| Vera Site # 0144 | Augusta | Georgia | 30912 | United States |
| Vera Site # 0147 | Lawrenceville | Georgia | 30046 | United States |
| Vera Site # 0109 | Chicago | Illinois | 60611 | United States |
| Vera Site # 0133 | Las Vegas | Nevada | 89106 | United States |
| Vera Site # 0149 | Summit | New Jersey | 07901 | United States |
| Vera Site # 0146 | New York | New York | 10016 | United States |
| Vera Site # 0142 | New York | New York | 10039 | United States |
| Vera Site # 0148 | Cleveland | Ohio | 44109 | United States |
| Vera Site # 0145 | Columbus | Ohio | 43210 | United States |
| Vera SIte # 0132 | Jackson | Tennessee | 38305 | United States |
| Vera Site # 0125 | Dallas | Texas | 75231 | United States |
| Vera Site # 0126 | Dallas | Texas | 75231 | United States |
| Vera Site # 0122 | El Paso | Texas | 79925 | United States |
| Vera Site # 0141 | Coto Laurel | 00780 | Puerto Rico |
| Vera Site # 0349 | A Coruña | 15006 | Spain |
| Vera Site # 0348 | Barcelona | 08035 | Spain |
| Vera Site # 0347 | Barcelona | 08036 | Spain |
| Vera Site #0351 | Santander | 39008 | Spain |
| Vera Site # 0350 | Seville | 41013 | Spain |
| Vera Site # 0346 | Valencia | 4601 | Spain |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C524618 | TACI receptor-IgG Fc fragment fusion protein |
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