Phase
Condition
Nephropathy
Nephritis
Nephrotic Syndrome
Treatment
Atacicept
Clinical Study ID
Ages > 10 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Key Exclusion Criteria
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.
Study Design
Study Description
Connect with a study center
Vera Therapeutics
Brisbane, California 94005
United StatesSite Not Available
Vera Therapeutics
Brisbane 5330810, California 5332921 94005
United StatesActive - Recruiting

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