Monthly Dosing of Atacicept in IgAN
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN
Sponsor: Vera Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
Time frame: Up to 24 weeks
Secondary Endpoints
To evaluate the safety and tolerability of atacicept at different dosing regimensT
To evaluate the effect of atacicept on serum immunoglobulins (IgA)
To evaluate the effect of atacicept on serum immunoglobulins (IgG)
Eligibility Criteria
Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments * Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments * Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years * Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample * eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1 Exclusion Criteria: * IgAN secondary to another condition (eg, liver cirrh…
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