Atacicept for Autoimmune Kidney Diseases

This study is testing a drug called atacicept to see how safe and effective it is for people with certain autoimmune kidney diseases. These conditions include IgA nephropathy (IgAN), primary membranous nephropathy (pMN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and nephrotic syndrome. Researchers will give participants 150 mg of atacicept as a shot under the skin once a week. The study will look at any side effects and changes in routine lab tests over 52 to 78 weeks. It will also measure how much protein is in your urine after 36 weeks. You might be able to join if you are at least 2 years old, weigh at least 40 kg, and have stable blood pressure. The study is currently unclear about its recruitment status and plans to enroll 250 participants.

Study design
This interventional study plans to enroll 250 participants. The phase of the study is not specified.
What's involved
Participants will receive atacicept 150 mg as a shot under the skin once a week. The study will monitor participants for 52 to 78 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until the end of the study, which is 52 to 78 weeks after starting.

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NCT06983028

Atacicept in Multiple Glomerular Diseases

Recruiting
PHASE2Ages 2+InterventionalTreatment
Vera Therapeutics, Inc.
~250 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Atacicept

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AE profile and results of routine clinical and laboratory tests
Measured over Baseline until end of study: 52 + 26 Weeks
+1 more outcome measured
pMN
IgAN
Nephrotic Syndrome
MCD
FSGS
1 sites across 1 states
California1
  • Pam Winterberg · STUDY_DIRECTOR · Vera Therapeutics
Vera Therapeutics, Inc. Clinical Trials Information
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Eligibility criteria

Inclusion

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.
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
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
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)
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

Exclusion

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.
  • AE profile and results of routine clinical and laboratory testsBaseline 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

  • Percent reduction in urine protein to creatinine ratio (UPCR)Baseline, Week 36

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