ClinicalTrials.gg
RecruitingNCT06983028Updated Jun 26, 2026

Atacicept in Multiple Glomerular Diseases

A Phase 2 interventional study of Atacicept in pMN, IgAN and Nephrotic Syndrome, sponsored by Vera Therapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Vera Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Non-randomized
Ages
2 Years and older
Sex
All
01

Study summary

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)
02

Conditions studied

  • 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)
  • 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
03

In context

Nephrotic Syndrome

191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.

This study's planned enrollment of 250 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.

Browse Nephrotic Syndrome studies →

Lead sponsor

Vera Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
  • proven IgAN, IgAVN, or recurrent IgAN in kidney transplant
  • UPCR ≥ 0.5 g/g or UPE ≥ 0.5 g/day on 24h urine
  • ≥ 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 (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

Key Exclusion Criteria:

  • 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 laboratory abnormalities that may interfere with participation in this study
  • Administration of live and within 30 days prior to enrollment
  • medications within 4 weeks prior to dosing with atacicept (except transplant maintenance immunosuppression).
  • Known to atacicept or any component of the formulated atacicept
  • Additional criteria apply to each cohort/disease.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    IgAN or IgAVN

    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.

    Drug: Atacicept

  • Experimental
    pMN

    Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease.

    Drug: Atacicept

  • Experimental
    Primary Nephrotic Syndrome (MCD/FSGS)

    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.

    Drug: Atacicept

Interventions

  • Atacicept 150 mg SC QW via pre-filled syringe

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline until end of study: 52 + 26 Weeks

  2. 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

    Time frame: Baseline, Week 36

Secondary outcomes

  1. Changes from baseline estimated glomerular filtration rate (eGFR).

    Changes from baseline in estimated glomerular filtration rate (eGFR).

    Time frame: Baseline, Week 36, Week 52

  2. 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).

    Time frame: Baseline through 52 Weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Nov 2027, 28 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2025
First posted
May 21, 2025
StartActual
Jul 7, 2025
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Jun 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06983028
Lead sponsor
Vera Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 21, 2025
Start date
Jul 7, 2025
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Jun 26, 2026

Study contacts

Vera Therapeutics, Inc. Clinical Trials Information
Contact
PIONEERStudy@veratx.com
650-770-0077
Pam Winterberg
study director · Vera Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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