FSGS, IgAN, MCD, Nephrotic Syndrome, pMN
Conditions
Keywords
IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA, Primary Membranous Nephropathy, Nephrotic Syndrome, Immunoglobulin A (IgA), Immunoglobulin A vasculitis with nephritis (IgAVN), Anti-PLA2R associated membranous nephropathy (PLA2R-MN), Idiopathic/primary nephrotic syndrome (MCD/FSGS), Glomerulonephritis, Nephritis, Autoimmune Diseases, Immune System Diseases, Kidney Diseases, Glomerulonephritis, IGA
Brief summary
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of Atacicept in multiple autoimmune glomerular diseasing including: * IgAN (IgA Nephropathy) * pMN (Primary Membranous Nephropathy) * MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis)
Interventions
DRUGAtacicept
Atacicept 150 mg SC QW via pre-filled syringe
Sponsors
Vera Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Weight of at least 40 kg * On a stable prescribed standard of care (SoC) treatment regimen according to local guidelines and the specific requirements for each disease * Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at Screening. Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome For patients enrolling in IgAN cohorts (eligibility varies by cohort): * Age ≥ 18 years * Biopsy proven IgAN, IgAVN, or recurrent IgAN in kidney transplant * UPCR ≥ 0.5 g/g or UPE ≥ 0.5 g/day on 24h urine * eGFR≥ 20 mL/min/1.73m2 For patients enrolling in pediatric IgAN Cohorts (eligibility varies by cohort): * Age ≥ 2 years and \< 18 years * Biopsy proven IgAN or IgAVN * On stable prescribed regimen of RAASi (or SoC) for at least 8 weeks * UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/d on 24h urine * eGFR≥ 30 mL/min/1.73m2 For patients enrolling in pMN cohorts (eligibility varies by cohort): * Age ≥ 18 years * Biopsy-proven pMN * Anti PLA2R antibodies ≥ 25 RU/mL * UPCR ≥ 1.5 g/g or UPE ≥ 1.5 g/d on 24h urine * At low risk for spontaneous remission (based on severity or duration of disease) For patients enrolling in Nephrotic Syndrome cohorts (MCD, FSGS, or pediatric idiopathic nephrotic syndrome): * Age ≥ 10 years * eGFR ≥30 mL/min/1.73m2 * Adults with biopsy diagnosis of primary MCD or FSGS (adults) or children with challenging clinical course with steroids (frequenlty relapsing, steroid-dependent, or steroid-resistant) * UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/d on 24h urine * Evidence of anti-nephrin antibodies Key
Exclusion criteria
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening) * Active viral or bacterial infections * Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study * Administration of live and live-attenuated vaccinations within 30 days prior to enrollment * Immunosuppressant medications within 4 weeks prior to dosing with atacicept (except transplant maintenance immunosuppression). * Known hypersensitivity to atacicept or any component of the formulated atacicept * Additional criteria apply to each cohort/disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE profile and results of routine clinical and laboratory tests | Baseline until end of study: 52 + 26 Weeks | Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs |
| Percent reduction in urine protein to creatinine ratio (UPCR) | Baseline, Week 36 | Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline estimated glomerular filtration rate (eGFR). | Baseline, Week 36, Week 52 | Changes from baseline in estimated glomerular filtration rate (eGFR). |
| Change in disease-specific antibodies | Baseline through 52 Weeks | 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). |
Countries
United States
Contacts
CONTACTVera Therapeutics, Inc. Clinical Trials Information
STUDY_DIRECTORPam Winterberg
Vera Therapeutics
Outcome results
None listed