A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
Vera Therapeutics, Inc.
Summary
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
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)
Eligibility
- Age range
- 2+ years
- Sex
- All
- 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 en…
Interventions
- DrugAtacicept
Atacicept 150 mg SC QW via pre-filled syringe
Location
- Vera TherapeuticsBrisbane, California