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A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
The purpose of this study is to evaluate the safety and efficacy of Atacicept in multiple autoimmune glomerular diseasing including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgAN or IgAVN | Experimental | Adult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included. |
|
| pMN | Experimental | Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease. |
|
| Primary Nephrotic Syndrome (MCD/FSGS) | Experimental | Adults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atacicept | Drug | Atacicept 150 mg SC QW via pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE profile and results of routine clinical and laboratory tests | Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs | Baseline until end of study: 52 + 26 Weeks |
| Percent reduction in urine protein to creatinine ratio (UPCR) | Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36 | Baseline, Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline estimated glomerular filtration rate (eGFR). | Changes from baseline in estimated glomerular filtration rate (eGFR). | Baseline, Week 36, Week 52 |
| Change in disease-specific antibodies |
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Inclusion Criteria:
Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome
For patients enrolling in IgAN cohorts (eligibility varies by cohort):
For patients enrolling in pediatric IgAN Cohorts (eligibility varies by cohort):
For patients enrolling in pMN cohorts (eligibility varies by cohort):
For patients enrolling in Nephrotic Syndrome cohorts (MCD, FSGS, or pediatric idiopathic nephrotic syndrome):
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vera Therapeutics, Inc. Clinical Trials Information | Contact | 650-770-0077 | PIONEERStudy@veratx.com |
| Name | Affiliation | Role |
|---|---|---|
| Pam Winterberg | Vera Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vera Therapeutics | Recruiting | Brisbane | California | 94005 | United States |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| C537834 | Macular dystrophy, corneal type 1 |
| D005922 | Glomerulonephritis, IGA |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C524618 | TACI receptor-IgG Fc fragment fusion protein |
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IgAN: Percent change from baseline galactose-deficient IgA1 (GdIgA1) levels at 36 and 52 weeks.
pMN: Percent change from baseline in anti-PLA2R antibody levels at 4, 8, 12, 36, and 52 weeks.
MCD/FSGS: Percent change from baseline anti-nephrin antibody levels at 4, 8, 12, 36, and 52 weeks (exploratory).
| Baseline through 52 Weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |