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Drug Highest PhaseNDA/BLA |
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一项将Atrasentan用于治疗存在进行性肾功能丧失风险的IgA肾病患者的III期、随机、双盲、安慰剂对照研究(ALIGN研究)
[Translation] A phase III, randomized, double-blind, placebo-controlled study of atrasentan in patients with IgA nephropathy at risk of progressive renal function loss (ALIGN study)
比较Atrasentan与安慰剂在存在进行性肾功能丧失风险的IgAN受试者中的疗效和安全性;主要评估第24周时Atrasentan与安慰剂对蛋白尿水平的影响;次要评估评估Atrasentan与安慰剂从基线到第136周(随机治疗停止后4周)对估算肾小球滤过率(eGFR)变化的影响;比较Atrasentan与安慰剂之间的eGFR 2年期治疗变化率(从随机治疗第12周到第120周的eGFR斜率);比较Atrasentan和安慰剂之间的eGFR总研究变化率(从基线到第136周的eGFR斜率)以及确定Atrasentan与安慰剂相比的安全性和耐受性特征。探索性评估与安慰剂相比,接受Atrasentan的受试者的生活质量(QOL);Atrasentan的稳态药代动力学(PK),为探索性暴露-反应分析提供支持;评估疾病生物标志物的变化以及其他安全性结局。
[Translation] Compare the efficacy and safety of Atrasentan versus placebo in IgAN subjects at risk of progressive renal function loss; Primary assessment of the effect of Atrasentan versus placebo on proteinuria levels at Week 24; Secondary assessments to evaluate the effect of Atrasentan versus placebo on the change in estimated glomerular filtration rate (eGFR) from baseline to Week 136 (4 weeks after cessation of randomized treatment); Compare the 2-year treatment change rate of eGFR between Atrasentan and placebo (eGFR slope from Week 12 of randomized treatment to Week 120); Compare the overall study change rate of eGFR between Atrasentan and placebo (eGFR slope from baseline to Week 136) and determine the safety and tolerability profile of Atrasentan compared to placebo. Exploratory assessment of the quality of life (QOL) of subjects receiving Atrasentan compared to placebo; Steady-state pharmacokinetics (PK) of Atrasentan to support exploratory exposure-response analysis; Assess changes in disease biomarkers and other safety outcomes.
100 Clinical Results associated with Chinook Therapeutics U.S., Inc.
0 Patents (Medical) associated with Chinook Therapeutics U.S., Inc.
100 Deals associated with Chinook Therapeutics U.S., Inc.
100 Translational Medicine associated with Chinook Therapeutics U.S., Inc.