Atacicept in Multiple Glomerular Diseases

Launched by VERA THERAPEUTICS, INC. · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called atacicept to see how safe it is and how well it works for people with certain kidney diseases, including primary membranous nephropathy (pMN), IgA nephropathy (IgAN), nephrotic syndrome, minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS). The goal is to find out if atacicept can help reduce protein in the urine and protect kidney function in adults and adolescents.

To participate in the trial, you need to be at least 10 years old and weigh at least 40 kg. You should also be receiving standard treatment for your kidney condition and have specific test results that meet the study's criteria. If you join the study, you will be closely monitored to see how well you tolerate the treatment and any effects it has on your kidney health. It's important to note that this trial is not yet recruiting participants, so you will need to wait for it to start before you can consider joining.

Gender

ALL

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
• • 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.