A phase 2b, randomized, double-blind, placebo-controlled, clinical trial of atacicept for treatment of IgA nephropathy

医学 安慰剂 肾病 双盲 内科学 随机对照试验 临床试验 内分泌学 糖尿病 替代医学 病理
作者
Richard A. Lafayette,Sean Barbour,Rubeen Israni,Xuelian Wei,Necmi Eren,Jürgen Floege,Vivekanand Jha,Sung Gyun Kim,Bart Maes,Richard Phoon,Harmeet Singh,Vladimı́r Tesař,Celia J. F. Lin,Jonathan Barratt
出处
期刊:Kidney International [Elsevier BV]
卷期号:105 (6): 1306-1315 被引量:37
标识
DOI:10.1016/j.kint.2024.03.012
摘要

Atacicept is a first-in-class, dual anti-B-cell Activation Factor–A Proliferation-Inducing Ligand fusion protein in clinical evaluation for treatment of IgA nephropathy. To compare efficacy and safety of atacicept versus placebo in patients with IgAN, this randomized, double-blind, placebo-controlled phase 2b clinical trial ORIGIN enrolled 116 individuals with biopsy-proven IgA nephropathy. Participants were randomized to atacicept 150, 75, or 25 mg versus placebo once weekly for up to 36 weeks. Primary and key secondary endpoints were changes in urine protein creatinine ratio based on 24-hour urine collection at weeks 24 and 36, respectively, in the combined atacicept 150 mg and 75 mg group versus placebo. The primary endpoint was met at week 24 as the mean urine protein creatinine ratio was reduced from baseline by 31% in the combined atacicept group versus 8% with placebo, resulting in a significant 25% reduction with atacicept versus placebo. At week 36, the key secondary endpoint was met as the mean urine protein creatinine ratio reduced from baseline by 34% in the combined atacicept group versus a 2% increase with placebo, resulting in a significant 35% reduction with atacicept versus placebo. The reduction in proteinuria was accompanied by stabilization in endpoint eGFR with atacicept compared to a decline with placebo at week 36, resulting in significant between-group geometric mean difference of 11%, approximating an absolute difference of 5.7 mL/min/1.73m 2. Endpoint galactose deficient IgA1 levels significantly decreased from baseline by 60% versus placebo. The safety profile of atacicept was like placebo. Thus, our results provide evidence to support a pivotal, phase 3 study of atacicept in IgA nephropathy.
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