Atacicept in Multiple Glomerular Diseases (PIONEER)
NCT06983028Sponsor: Vera Therapeutics, Inc.
Principal investigator
Actively Recruiting
About This Study
This Phase 2 study evaluates the safety, tolerability, and efficacy of atacicept in adult and adolescent patients aged 10 and older with autoimmune glomerular diseases. The target population includes patients diagnosed with IgAN, pMN, MCD, or FSGS. Participants receive weekly subcutaneous injections of atacicept to determine its impact on reducing UPCR and preserving renal function. Primary endpoints focus on the drug's safety profile and its ability to achieve clinical remission across these specific nephropathies.
Who Can Participate?
✓ Inclusion Criteria
- •Weight ≥ 40 kg
- •Diagnosis of IgAN
- •Diagnosis of IgAVN
- •On a stable standard-of-care treatment regimen per local guidelines and disease-specific requirements
- •SBP ≤ 160 mmHg and DBP ≤ 90 mmHg
- •Age 10-17 years
- •Biopsy-confirmed disease
- •eGFR ≥ 20 mL/min/1.73 m² (IgAN cohorts)
- •Low likelihood of spontaneous remission based on disease severity or duration
- •ACR > 1.0 g/g
✗ Exclusion Criteria
- •Evidence of rapidly progressive glomerulonephritis (≥ 50% eGFR loss) within 3 months prior to and at Screening
- •Active viral or bacterial infection
- •Existing conditions or clinically significant lab abnormalities that may interfere with study participation
- •Receipt of live or live-attenuated vaccines within 30 days prior to enrollment
- •Known hypersensitivity to atacicept or any component of the formulated product
- •Additional cohort/disease-specific eligibility criteria apply