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Atacicept in Subjects With IgA Nephropathy
About
Brief Summary
A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 creatinine ratio (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 Epidemiology Collaboration (CKD-EPI) equation.
- On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
- Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg
Key Exclusion Criteria:
- IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial 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 3 months of screening)
- Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association 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 of active TB determined by a positive Quantiferon test
- Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept
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Study Stats
Protocol No.
23-5139
Category
Genitourinary Disorders
Principal Investigator
Contact
- Christina Lopez
- Jessica Gomez
Location
- UCLA Westwood