NCT06983028RecruitingPhase 2
Atacicept in Multiple Glomerular Diseases
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 13 May 2025
- Start date
- 7 Jul 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Vera Therapeutics, Inc.
- Diseases
- IgA nephropathy
- NCT number
- NCT06983028
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 250
- From 7 Jul 2025 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Active viral or bacterial infections
- Known hypersensitivity to atacicept or any component of the formulated atacicept
- Additional criteria apply to each cohort/disease.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vera Therapeutics Coordinator of this site? Confirm its status | Brisbane | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.