A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
Sponsor: Vera Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of adverse events observed during the dosing period
Time frame: Baseline until end of study up to week156
Secondary Endpoints
To evaluate the effect of atacicept on change in proteinuria
To evaluate the effect of atacicept on the change in estimated glomerular filtration rate (eGFR) using serum creatinine and cystatin C, respectively
To evaluate the effect of atacicept on hematuria
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 * 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 urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies: * Is not a woman of childbearing potential (WOCBP) OR * Is a WOCBP who agrees to use a highly effective contraceptive method (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the las…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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