Atacicept in Multiple Glomerular Diseases

NCT06983028 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VT-001-0060
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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); Immunoglobulin A vasculitis with nephritis (IgAVN); Anti-PLA2R associated membranous nephropathy (PLA2R-MN); Idiopathic/primary nephrotic syndrome (MCD/FSGS); Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Glomerulonephritis, IGA

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline, Week 36

Secondary Outcomes (2)

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

  Baseline, Week 36, Week 52

• Change in disease-specific antibodies

  Baseline through 52 Weeks

Study Arms (3)

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.

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.

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.

Drug: Atacicept

Interventions

Atacicept DRUG

Atacicept 150 mg SC QW via pre-filled syringe

IgAN or IgAVN; Primary Nephrotic Syndrome (MCD/FSGS); pMN

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vera Therapeutics, Inc.: lead

Study Sites (1)

Vera Therapeutics

Brisbane, California, 94005, United States

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome; Macular dystrophy, corneal type 1; Glomerulonephritis, IGA; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Kidney Diseases

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Nephrosis

Study Officials

• Pam Winterberg

  Vera Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Vera Therapeutics, Inc. Clinical Trials Information

CONTACT

650-770-0077; PIONEERStudy@veratx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)