What is Atacicept studying for autoimmune kidney diseases?

Atacicept is being studied to evaluate its safety and effects on multiple autoimmune kidney diseases like IgA Nephropathy, Primary Membranous Nephropathy, and nephrotic syndrome. The research aims to understand how well this treatment works and monitor any side effects during the study period. Vera Therapeutics, Inc. is sponsoring this investigation to improve treatment options for these conditions.

Who may be eligible for this autoimmune kidney disease clinical trial?

Adults and children aged 2 years and older with biopsy-proven autoimmune kidney diseases such as IgA Nephropathy, pMN, or nephrotic syndrome may be eligible. Participants must have stable standard care treatment, controlled blood pressure, and weigh at least 40 kg. Certain antibody and kidney function levels are also required. Please review eligibility criteria for more details.

Is there any cost to participate in this autoimmune kidney disease clinical trial?

Study-related care, including the study drug Atacicept and all trial visits, is provided at no cost. However, personal expenses like travel to and from visits may vary and are not guaranteed to be covered. Participants should plan accordingly for these costs.

Actively Recruiting

Phase 2

Age: 2Years +

All Genders

ID06983028

Phase 2 Study Evaluating Safety and Effectiveness of Atacicept in Autoimmune Kidney Diseases Including IgA Nephropathy, Primary Membranous Nephropathy, and Nephrotic Syndrome

Led by Vera Therapeutics, Inc. · Updated on 2026-06-26

250

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying how well Atacicept works and how safe it is for people with several autoimmune kidney diseases, including IgA Nephropathy, Primary Membranous Nephropathy, and Minimal Change Disease or Focal Segmental Glomerulosclerosis. This Phase 2 trial aims to evaluate Atacicepts effects on these conditions, which involve immune system attacks on the kidneys filtering units. The study includes adults and children with biopsy-proven diagnoses and specific disease characteristics. Participants receive Atacicept as a 150 mg injection under the skin once a week using a pre-filled syringe. The trial includes groups with different kidney diseases adults and children with IgAN or IgAVN, adults with pMN linked to anti-PLA2R antibodies, and adults or children with nephrotic syndrome related to MCD or FSGS and anti-nephrin antibodies. Treatment and monitoring occur over a planned period of 52 weeks plus an additional 26 weeks of follow-up. During the study, participants will have regular clinical and lab tests to monitor safety and kidney function, including urine protein measurements and blood tests for kidney filtration rate and disease markers. Researchers will track adverse events and changes in specific antibodies related to these diseases. The total study duration includes baseline assessments, treatment, and extended observation, with safety and kidney health closely followed throughout.

CONDITIONS

Brief Title

Atacicept in Multiple Glomerular Diseases

Who Can Participate

Age: 2Years +

All Genders

Eligibility Criteria

You may qualify if you...

Weight of at least 40 kg
On a stable prescribed standard of care treatment regimen according to local guidelines
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 IgAN adult cohorts: Age ≥ 18 years, biopsy-proven IgAN, IgAVN, or recurrent IgAN in kidney transplant, UPCR ≥ 0.5 g/g or UPE ≥ 0.5 g/day, eGFR ≥ 20 mL/min/1.73m2
For pediatric IgAN cohorts: Age ≥ 2 and < 18 years, biopsy-proven IgAN or IgAVN, on stable RAASi or standard care for at least 8 weeks, UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/day, eGFR ≥ 30 mL/min/1.73m2
For pMN cohorts: Age ≥ 18 years, biopsy-proven pMN, anti-PLA2R antibodies ≥ 25 RU/mL, UPCR ≥ 1.5 g/g or UPE ≥ 1.5 g/day, low risk for spontaneous remission
For Nephrotic Syndrome cohorts: Age ≥ 10 years, eGFR ≥ 30 mL/min/1.73m2, adults with biopsy diagnosis of primary MCD or FSGS or children with challenging steroid-responsive nephrotic syndrome, UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/day, evidence of anti-nephrin antibodies

You will not qualify if you...

Evidence of rapidly progressive glomerulonephritis with loss of ≥50% eGFR within 12 weeks prior to and at Screening
Active viral or bacterial infections
Existing conditions or significant lab abnormalities interfering with study participation
Live or live-attenuated vaccinations within 30 days prior to enrollment
Immunosuppressant medications within 4 weeks prior to dosing (except transplant maintenance immunosuppression)
Known hypersensitivity to Atacicept or its components
Additional criteria apply to each specific disease cohort

Research Team

Vera Therapeutics, Inc. Clinical Trials Information

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Phase 2 Study Evaluating Safety and Effectiveness of Atacicept in Autoimmune Kidney Diseases Including IgA Nephropathy, Primary Membranous Nephropathy, and Nephrotic Syndrome

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria