Clinical Trial Finder

Atacicept in Multiple Glomerular Diseases

Study Purpose

The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 10 Years and Over
Gender All
More 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.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06983028
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Vera Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pam Winterberg
Principal Investigator Affiliation Vera Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 pMN, IgAN, Nephrotic Syndrome, MCD, FSGS
Additional Details

The study will assess the safety and efficacy of atacicept in multiple autoimmune glomerular diseases including IgAN (IgA Nephropathy), pMN (Primary Membranous Nephropathy) and MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis) in participants ages 10 and above with weekly SC injections.

Arms & Interventions

Arms

Experimental: IgAN or IgAVN

Adult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included.

Experimental: pMN

Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease.

Experimental: Primary Nephrotic Syndrome (MCD/FSGS)

Adults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies.

Interventions

Drug: - Atacicept

Atacicept 150 mg SC QW via pre-filled syringe

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vera Therapeutics, Brisbane 5330810, California 5332921

Status

Recruiting

Address

Vera Therapeutics

Brisbane 5330810, California 5332921, 94005

Site Contact

Brisbane, California

[email protected]

(650)770-0077

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