A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN 3

Israni Rubeen0 个研究点目标入组 36 人开始时间: 2024年2月14日最近更新: 2024年5月27日

试验速览

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•1. Must have the ability to understand and sign a written informed consent form
•2. Male or female of >=18 years of age
•3. 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
•4. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
•5. eGFR >=30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
•6. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
•7. Systolic blood pressure <=150 mmHg and less, and diastolic blood pressure <=90 mmHg

•1. 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
•2. 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
•3. Evidence of rapidly progressive glomerulonephritis (loss of >=50% of eGFR within 3 months of screening)
•4. Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg
•5. Renal or other organ transplantation prior to, or expected during the study
•6. Concomitant chronic renal disease in addition to IgAN
•7. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
•8. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
•9. Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

发起方

Israni Rubeen