Vera Therapeutics, Inc.
The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.
Eligible participants will receive atacicept 150 mg once weekly (QW) self-administered subcutaneously (SC). Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1: Atacicept Drug Holiday) or are continuing atacicept with no disruption in treatment (Group 2: Continuous Atacicept Treatment). Long-term safety and tolerability of atacicept is assessed by routine clinical and laboratory tests and adverse events.
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 * Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN * For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90mmHg at screening and Day 1 * A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative ur…
The atacicept drug product is available as a ready to use injection solution in the following prefilled syringe (PFS) that is composed of: \*BD Hypak™ SCF™ Barrel Glass barrel 1ml long with staked needle 27G ½" 5B with Rigid Needle Shield BD260 \*BD SCF™ Stopper 1ml long W4023 Flurotec
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