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初次IgA腎不全 (NefIgArd) の患者におけるブデソニドの標的放出剤の有効性と安全性: ランダム化第3相試験の2年間の結果
Richard Lafayette1, Jens Kristensen2, Andrew Stone3
1Division of Nephrology, Department of Medicine, Stanford University, Stanford, CA, USA.
Lancet (London, England)
|August 17, 2023
PubMed で要約を見る
まとめ
経口用ブデソニド製剤であるネフェコンは,IgA腎不全患者の腎機能低下を2年間にわたって著しく遅らせました. この治療は病気を変化させる効果を示し,耐受性があり,IgA腎不全の管理に新しい選択肢を提供しました.
科学分野:
- 腎臓科
- 免疫学
- 薬理学について
背景:
- IgA腎不全は,慢性腎疾患と腎不全の主要な原因です.
- 腸内免疫系は,IgA腎不全の病原化に作用する.
- ネフェコンは,腸内粘膜免疫を標的とした新しい経口ブデソニド製剤です.
研究 の 目的:
- IgA腎不全の患者におけるNefeconの有効性と安全性を評価する.
- 2年間にわたって推定される球過濾率 (eGFR) の低下に対するネフェコンの効果を評価する.
- IgA腎不全患者のタンパク質尿に対するNefeconの影響を決定する.
主な方法:
- 2年,フェーズ3,多センター,ランダム化,ダブルブラインド,プラセボ対照試験 (NefIgArd).
- 9ヶ月間,IgA腎不全と持続したタンパク質尿を患った成人患者は,ネフェコン (16 mg/日) またはプラセボを投与し,その後15ヶ月間観察した.
- 主なエンドポイントは2年間の時間加重平均のeGFRでした.
主要な成果:
- ネフェコンは,プラセボと比較して2年間にわたってEGFRの減少を5. 05mL/ min/ 1. 73m2減速させ,統計的に有意な治療効果を示した.
- プラセボ (7. 52 mL/ min/ 1. 73 m2) と比較して,ネフェコンを投与した患者のEGFRの時間加重平均の変化が遅かった.
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