Atacicept in Multiple Glomerular Diseases

Last updated: January 16, 2026
Sponsor: Vera Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Nephropathy

Nephritis

Nephrotic Syndrome

Treatment

Atacicept

Clinical Study ID

NCT06983028
VT-001-0060
  • Ages > 10
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

Eligibility Criteria

Inclusion

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. For participants aged ≥10 to <18 years, the average of 3 separate systolic and/or diastolic blood pressures <95th percentile for age, gender, and height

Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome

For patients enrolling in IgAN cohorts (eligibility varies by cohort):

  • Age ≥ 10 years

  • Biopsy proven IgAN or IgAVN,

  • UPCR ≥ 0.5 g/g

  • eGFR≥ 20 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

  • 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

  • Biopsy diagnosis of primary MCD or FSGS (adults) or challenging clinical course with steroids in children (frequenlty relapsing, steroid-dependent, or steroid-resistant)

  • UPCR ≥ 1.0 g/g at Screening,

  • Evidence of anti-nephrin antibodies

Key Exclusion Criteria

  • Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 3 months 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

  • Known hypersensitivity to atacicept or any component of the formulated atacicept

  • Additional criteria apply to each cohort/disease.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Atacicept
Phase: 2
Study Start date:
July 07, 2025
Estimated Completion Date:
November 30, 2027

Study Description

The study will assess the safety and efficacy of atacicept in multiple autoimmune glomerular diseases including IgAN (IgA Nephropathy), pMN (Primary Membranous Nephropathy) and MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis) in participants ages 10 and above with weekly SC injections.

Connect with a study center

  • Vera Therapeutics

    Brisbane, California 94005
    United States

    Site Not Available

  • Vera Therapeutics

    Brisbane 5330810, California 5332921 94005
    United States

    Active - Recruiting

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