pMNPhase 2NCT06983028
Atacicept in Multiple Glomerular Diseases
A Phase 2 study testing Atacicept in people with pMN and IgAN, run by Vera Therapeutics, Inc. at 1 site in United States.
Trial summary
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- pMN, IgAN, Nephrotic Syndrome
- What is being tested?
- Atacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening)
- Active viral or bacterial infections
- Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
- 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).
- Known hypersensitivity to atacicept or any component of the formulated atacicept
- Additional criteria apply to each cohort/disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vera Therapeutics
Brisbane, California, 94005
Brisbane, California, (650)770-0077, clinicaltrials@veratx.com
About this study
Official title: 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.
Read the detailed 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)
- Conditions
- pMN, IgAN, Nephrotic Syndrome, MCD, FSGS
- Being tested
- Atacicept
- Keywords
- IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA, Primary Membranous Nephropathy, Nephrotic Syndrome, Immunoglobulin A (IgA), Immunoglobulin A vasculitis with nephritis (IgAVN), Anti-PLA2R associated membranous nephropathy (PLA2R-MN), Idiopathic/primary nephrotic syndrome (MCD/FSGS), Glomerulonephritis, Nephritis, Autoimmune Diseases, Immune System Diseases, Kidney Diseases, Glomerulonephritis, IGA
- Medical subject headings
- Nephrotic Syndrome, Macular dystrophy, corneal type 1, Glomerulonephritis, IGA, Glomerulonephritis, Nephritis, Autoimmune Diseases, Immune System Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciceptDrug
Atacicept 150 mg SC QW via pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| IgAN or IgAVN | Experimental | Adult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included. Receives: Drug: Atacicept |
| pMN | Experimental | Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease. Receives: Drug: Atacicept |
| Primary Nephrotic Syndrome (MCD/FSGS) | Experimental | Adults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies. Receives: Drug: Atacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE profile and results of routine clinical and laboratory tests
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs
Measured: Baseline until end of study: 52 + 26 Weeks
Percent reduction in urine protein to creatinine ratio (UPCR)
Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36
Measured: Baseline, Week 36
Secondary outcomes (2)
Changes from baseline estimated glomerular filtration rate (eGFR).
Changes from baseline in estimated glomerular filtration rate (eGFR).
Measured: Baseline, Week 36, Week 52
Change in disease-specific antibodies
IgAN: Percent change from baseline galactose-deficient IgA1 (GdIgA1) levels at 36 and 52 weeks.
pMN: Percent change from baseline in anti-PLA2R antibody levels at 4, 8, 12, 36, and 52 weeks.
MCD/FSGS: Percent change from baseline anti-nephrin antibody levels at 4, 8, 12, 36, and 52 weeks (exploratory).
Measured: Baseline through 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start7 Jul 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for pMNStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pam Winterberg, Study director, Vera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983028
- Sponsor's protocol ID
- VT-001-0060
- Status last verified
- Jun 2026
- First submitted
- 13 May 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
- ClinicalTrials.gov ID
- NCT06983028
- Acronym / sponsor ID
- VT-001-0060
- Conditions
- pMN, IgAN, Nephrotic Syndrome, MCD, FSGS
- Keywords
- IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA, Primary Membranous Nephropathy, Nephrotic Syndrome, Immunoglobulin A (IgA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Vera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IgAN or IgAVN | Experimental | Drug: AtaciceptAdult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included. |
| pMN | Experimental | Drug: AtaciceptAdults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease. |
| Primary Nephrotic Syndrome (MCD/FSGS) | Experimental | Drug: AtaciceptAdults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (27 listed)
- 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
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening)
- Active viral or bacterial infections
- Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtaciceptAtacicept 150 mg SC QW via pre-filled syringe | Drug | IgAN or IgAVN, Primary Nephrotic Syndrome (MCD/FSGS), pMN |
Primary outcome
AE profile and results of routine clinical and laboratory tests
Time frame: Baseline until end of study: 52 + 26 Weeks
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs
Percent reduction in urine protein to creatinine ratio (UPCR)
Time frame: Baseline, Week 36
Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36
2 secondary outcomes
Changes from baseline estimated glomerular filtration rate (eGFR).
Time frame: Baseline, Week 36, Week 52
Change in disease-specific antibodies
Time frame: Baseline through 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pam Winterberg study director
Vera Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atacicept in people with pMN and IgAN, run by Vera Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Therapeutics, Inc. Clinical Trials Information (650-770-0077, PIONEERStudy@veratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE profile and results of routine clinical and laboratory tests (time frame: Baseline until end of study: 52 + 26 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.