Recruiting
Phase 2

Atacicept

Sponsor:

Vera Therapeutics, Inc.

Code:

NCT06983028

Conditions

pMN

IgAN

Nephrotic Syndrome

MCD

FSGS

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Atacicept

Study Details

Brief summary:

A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.

Conditions

pMN

IgAN

Nephrotic Syndrome

MCD

FSGS

Study ID

NCT06983028

Start date

Jul 7, 2025

Status verified date

Jun, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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
  • 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

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 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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

experimental: pMN

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

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.

Interventions

Atacicept

Atacicept 150 mg SC QW via pre-filled syringe

Primary outcome measure

  • AE profile and results of routine clinical and laboratory tests [ Time Frame: Baseline until end of study: 52 + 26 Weeks ]
  • Percent reduction in urine protein to creatinine ratio (UPCR) [ Time Frame: Baseline, Week 36 ]

Central Contacts and Locations

Central contacts

Vera Therapeutics, Inc. Clinical Trials Information

650-770-0077PIONEERStudy@veratx.com

Locations

Vera Therapeutics

Recruiting

Brisbane, California, United States, 94005

Contacts

Brisbane, California

(650)770-0077clinicaltrials@veratx.com

More Information

Sponsor

Vera Therapeutics, Inc.

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vera Therapeutics, Inc. on 2026-06-26.