Atacicept in Multiple Glomerular Diseases

NCT ID: NCT06983028

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2027-11-30

Brief 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.

Detailed 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.

Conditions

pMN; IgAN; Nephrotic Syndrome; MCD; FSGS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Atacicept

Intervention Type: DRUG

Atacicept 150 mg SC QW via pre-filled syringe

pMN

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

Group Type: EXPERIMENTAL

Atacicept

Intervention Type: DRUG

Atacicept 150 mg SC QW via pre-filled syringe

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.

Group Type: EXPERIMENTAL

Atacicept

Intervention Type: DRUG

Atacicept 150 mg SC QW via pre-filled syringe

Interventions

Atacicept

Atacicept 150 mg SC QW via pre-filled syringe

Intervention Type: DRUG

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. 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

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vera Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pam Winterberg

Role: STUDY_DIRECTOR

Vera Therapeutics

Locations

Vera Therapeutics

Brisbane, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vera Therapeutics, Inc. Clinical Trials Information

Role: CONTACT

PIONEERStudy@veratx.com

650-770-0077

Facility Contacts

Brisbane, California

Role: primary

clinicaltrials@veratx.com

(650)770-0077

Other Identifiers

VT-001-0060

Identifier Type: -

Identifier Source: org_study_id