Phase
Condition
Kidney Disease
Nephropathy
Nephritis
Treatment
Atacicept
Placebo to match Atacicept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must have the ability to understand and sign a written informed consent form
Male or female of ≥18 years of age
Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinineratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) equation.
On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximumlabeled or tolerated dose at Screening
Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg
Exclusion
Key Exclusion Criteria:
IgAN secondary to another condition (e.g., liver cirrhosis), or other causes ofmesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura),systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3months of screening)
Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L inassociation with UPCR >3.5 mg/mg
Renal or other organ transplantation prior to, or expected during the study
Concomitant chronic renal disease in addition to IgAN
Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence ofactive TB determined by a positive Quantiferon test
Participation in the Phase 2b (Parts A and B) study or any previous treatment withatacicept
Study Design
Study Description
Connect with a study center
ORIGIN 3 Global Site Contact Information
Brisbane, California 94005
United StatesSite Not Available

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