Atacicept in Multiple Glomerular Diseases

NCT06983028
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
250
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Lead sponsor
Vera Therapeutics, Inc.
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Start date
2025-07-07
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Number of sites
1
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Summary
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
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Short title
Atacicept in Multiple Glomerular Diseases
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Official title
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-11-01
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First posted
2025-05-21
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Registry last updated
2026-06-26
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Primary completion date
2027-11-01
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Start date
2025-07-07
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
3
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Vera Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06983028
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ClinicalTrials.gov ID
NCT06983028
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. AE profile and results of routine clinical and laboratory tests

    Timeframe: Baseline until end of study: 52 + 26 Weeks

    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs

  2. Percent reduction in urine protein to creatinine ratio (UPCR)

    Timeframe: Baseline, Week 36

    Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36

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

    Timeframe: Baseline, Week 36, Week 52

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

  2. Change in disease-specific antibodies

    Timeframe: Baseline through 52 Weeks

    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).

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
2 Years
Healthy volunteers
No

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Vera TherapeuticsBrisbane, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

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