Tests atacicept in people with autoimmune kidney diseases
Tests atacicept in people with autoimmune kidney diseases affecting the glomeruli.
Plain-language title generated from the registry record
Registry title: Atacicept in Multiple Glomerular Diseases
Key facts
- Where
- Brisbane, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Vera TherapeuticsBrisbane, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vera Therapeutics, Inc.
- Trial code
- NCT06983028
- Record updated
- 26 June 2026
- Original description
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.Read full original descriptionShow less
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
Inclusion: 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.
Exclusion: 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); Active viral or bacterial infections; Known hypersensitivity to atacicept or any component of the formulated atacicept; Additional criteria apply to each cohort/disease; Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening); Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study.