Actively Recruiting
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
Led by Vera Therapeutics, Inc. · Updated on 2026-01-20
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of atacicept in adults and adolescents with multiple autoimmune glomerular diseases, including IgA Nephropathy (IgAN), Primary Membranous Nephropathy (pMN), and Minimal Change Disease/Focal Segmental Glomerulosclerosis (MCD/FSGS). The study aims to measure how atacicept affects proteinuria reduction and kidney function preservation in these conditions. Participants will receive weekly subcutaneous injections of atacicept at a dose of 150 mg using a pre-filled syringe. The study includes groups with biopsy-proven diagnoses: IgAN or IgAVN patients with varying proteinuria and kidney function, adults with pMN and anti-PLA2R antibodies at low remission risk, and patients with primary nephrotic syndrome including MCD, FSGS, or pediatric nephrotic syndrome with anti-nephrin antibodies. The treatment period lasts 52 weeks with additional follow-up. During the study, participants will undergo routine clinical and laboratory tests to monitor adverse events and kidney function changes, including urine protein to creatinine ratio and estimated glomerular filtration rate. Disease-specific antibody levels will also be tracked. The total study duration includes 52 weeks of treatment plus 26 weeks of follow-up to assess safety and effects on kidney disease.
CONDITIONS
Brief Title
Atacicept in Multiple Glomerular Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Weight of at least 40 kg
- On a stable prescribed standard of care treatment according to local guidelines
- Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at screening
- For ages 10 to <18 years, blood pressure below the 95th percentile for age, gender, and height
- Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome
- For IgAN cohorts: age ≥10 years, biopsy-proven IgAN or IgAVN, UPCR ≥0.5 g/g, eGFR ≥20 mL/min/1.73m2
- For pMN cohorts: age ≥18 years, biopsy-proven pMN, anti-PLA2R antibodies ≥25 RU/mL, UPCR ≥1.5 g/g, low risk of spontaneous remission
- For Nephrotic Syndrome cohorts: age ≥10 years, eGFR ≥30 mL/min/1.73m2, biopsy diagnosis of primary MCD or FSGS (adults) or challenging steroid course in children, UPCR ≥1.0 g/g, evidence of anti-nephrin antibodies
You will not qualify if you...
- Evidence of rapidly progressive glomerulonephritis with loss of ≥50% eGFR within 3 months prior to screening
- Active viral or bacterial infections
- Clinically significant laboratory abnormalities or conditions interfering with study participation
- Receipt of live or live-attenuated vaccinations within 30 days prior to enrollment
- Known hypersensitivity to atacicept or its components
- Additional specific criteria apply to each disease cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive weekly subcutaneous injections of atacicept to assess safety and efficacy in autoimmune glomerular diseases.
Weekly visits for up to 52 weeks
Duration - 26 weeks
Participants are monitored for safety and efficacy outcomes after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Vera Therapeutics
Brisbane, California, United States, 94005
Actively Recruiting
Research Team
V
Vera Therapeutics, Inc. Clinical Trials Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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