IgA腎不全の患者におけるスパルセンタン: ランダム化,ダブルブラインド,アクティブコントロールの臨床試験から得られた事前分析
Hiddo J L Heerspink1, Jai Radhakrishnan2, Charles E Alpers3
1Department of Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, Netherlands; The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Lancet (London, England)
|April 4, 2023
まとめ
イルベサタンと比較して,IgA腎不全患者のタンパク質尿を有意に減少させた. この新しい二重エンドセリンおよびアンジオテンシン受容体抗体が,中間分析でイルベサタンと同様の安全性を示した.
科学分野:
- 腎臓科
- 薬理学について
- 臨床試験
背景:
- IgA腎不全は慢性腎疾患である.
- スパーセンタンは新しい二重エンドセリンおよびアンジオテンシン受容体の抗体です.
- 現在,IgA腎不全の治療には限界があります.
研究 の 目的:
- IgA腎不全の成人におけるスパルセンタンの有効性と安全性を評価する.
- スパルセタンとイルベサタンのタンパク質尿減少を比較する.
- 治療に起因する有害事象の評価
主な方法:
- 国際的,ランダム化,ダブルブラインド,アクティブコントロールのフェーズ3試験 (PROTECT試験)
- 404人のIgA腎不全とタンパク質尿患者は,スパルセンタン (400 mg/日) またはイルベサタン (300 mg/日) を投与された.
- 主なエンドポイントは,尿中のタンパク質とクレアチニンの比率の変化でした.
主要な成果:
- Sparsentanは36週間でイルベサタン (-15. 1%) と比較して統計的に有意なタンパク質尿の減少を示しました.
- これは,スパルセンタンに有利なタンパク質尿の相対的な減少を41%を表しています.
- 治療に起因する有害事象はグループごとに類似しており,深刻な安全性に関する懸念は報告されていません.
結論:
- スパーセンタンは,IgA腎不全患者のタンパク質尿を有意に減少させます.
- スパーセンタンの安全性はイルベサタンと同等です.
- スパルセンタンの長期的な腎臓保護の可能性は,さらなる研究によって決定されます.
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