Atacicept for multiple autoimmune glomerular diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safety, tolerability, and how the body handles SK-09

  This trial will test single and repeated oral doses of SK-09 for safety and to see how the body processes them in healthy adults aged 18–55.

  Recruiting Phase 1 Consun Pharmaceutical Group · Herston, Queensland · NCT07267026

• Observational study on kidney transplant recurrence in FSGS and MCD

  This study is looking at patients with kidney diseases called FSGS and MCD who have had or will have a kidney transplant to see how often these diseases come back afterward.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT05650619

• Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome

  This study talks to patients and parents about their experiences with swelling from Nephrotic Syndrome to help create better ways to measure how new treatments work.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT05505500

• NEPTUNE Match: Personalized matching of patients to kidney treatment options

  This project will try a system that matches people in the NEPTUNE cohort who have nephrotic syndromes or related kidney diseases with suitable clinical trials and shares those matches with patients and their doctors.

  Recruiting at 15 sites University of Michigan · Atlanta, Georgia and 15 other locations · NCT04571658

• Safety and helpful dose test of STL303 in adults with IgA nephropathy

  A small, multi-center study will test different doses of STL303 or placebo to see if it helps adults with primary IgA nephropathy.

  Recruiting at 6 sites Phase 2 Sitala Bio LTD · Newcastle, New South Wales and 7 other locations · NCT07606352

• Smartphone app to help follow the 2024 KDIGO chronic kidney disease guidelines

  This project will test whether a smartphone app helps young adults (ages 16–29) with chronic kidney disease follow the 2024 KDIGO guideline recommendations.

  Recruiting at 2 sites St. James's Hospital, Ireland · Dublin and 1 other locations · NCT07561957

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.