Atacicept in Multiple Glomerular Diseases
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
Sponsor: Vera Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
AE profile and results of routine clinical and laboratory tests
Time frame: Baseline until end of study: 52 + 26 Weeks
Percent reduction in urine protein to creatinine ratio (UPCR)
Time frame: Baseline, Week 36
Secondary Endpoints
Changes from baseline estimated glomerular filtration rate (eGFR).
Change in disease-specific antibodies
Eligibility 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 idiopat…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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