Atacicept for multiple autoimmune glomerular diseases
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
This will test whether weekly injections of atacicept can lower protein in the urine and help preserve kidney function in people aged 10 and older with IgA nephropathy, primary membranous nephropathy, or nephrotic syndromes such as MCD and FSGS.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Vera Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Brisbane, California) |
| Trial ID | NCT06983028 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives weekly subcutaneous injections of atacicept to adolescent and adult participants with a range of autoimmune glomerular diseases to characterize safety, tolerability, and effects on proteinuria and renal function. Participants must be on a stable standard-of-care regimen and meet disease-specific criteria such as biopsy confirmation for IgAN or pMN and UPCR thresholds. Key outcome measures include adverse events, changes in urine protein-to-creatinine ratio, and measures of eGFR over the treatment period. The trial is sponsored by Vera Therapeutics and conducted at their Brisbane, California site.
Who should consider this trial
Good fit: Ideal candidates are people aged 10 or older who weigh at least 40 kg, are on a stable standard-of-care regimen, and meet disease-specific criteria such as biopsy-proven IgAN or pMN with required UPCR and antibody thresholds and acceptable baseline kidney function.
Not a fit: Patients with advanced kidney failure below the study thresholds, those who do not meet biopsy or biomarker criteria, children under 10 or under 40 kg, or those with unstable blood pressure are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, atacicept could reduce proteinuria and slow loss of kidney function in people with these autoimmune glomerular diseases.
How similar studies have performed: Other B-cell/BAFF-APRIL–targeting therapies have shown benefit in some autoimmune kidney conditions, but atacicept's use across these glomerular diseases is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Brisbane, California
- Vera Therapeutics — Brisbane, California, United States (Recruiting)
Study contacts
- Study coordinator: Vera Therapeutics, Inc. Clinical Trials Information
- Email: PIONEERStudy@veratx.com
- Phone: 650-770-0077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.