JP2020519904A - 腎代替療法の管理におけるインスリン様増殖因子結合タンパク質7および組織メタロプロテアーゼ阻害物質2の使用 - Google Patents
腎代替療法の管理におけるインスリン様増殖因子結合タンパク質7および組織メタロプロテアーゼ阻害物質2の使用 Download PDFInfo
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Abstract
Description
本出願は、全ての表、図面、および特許請求の範囲を含む全体が本明細書中参照によって組み込まれている、2017年5月7日に出願の米国特許仮出願第62/502,728号の利益を請求する。
「リスク」:ベースラインと比較して1.5倍増加した血清クレアチニン、または6時間にわたる尿産生<0.5ml/kg体重/hr;
「損傷」:ベースラインと比較して2.0倍増加した血清クレアチニン、または12時間にわたる尿産生<0.5ml/kg/hr;
「不全」:ベースラインと比較して3.0倍増加した血清クレアチニン、または24時間にわたるクレアチニン>355μmol/l(44超の上昇を伴う)もしくは0.3ml/kg/hr未満の尿量、または少なくとも12時間にわたる無尿;
これに2つの臨床転帰が含まれる:
「喪失」:4週間超の腎代替療法の必要性が続くこと。
「ERSD」:末期の腎疾患−3ケ月超の透析が必要。
「ステージI」:0.3mg/dL以上(≧26.4μmol/L)の血清クレアチニンの増加、またはベースラインと比較して150%(1.5倍)以上の増加、または6時間超にわたる1時間あたり0.5mL/kg未満の尿量;
「ステージII」:ベースラインと比較して200%超(2倍超)の血清クレアチニンの増加、または12時間超にわたる1時間あたり0.5mL/kg未満の尿量;
「ステージIII」:ベースラインと比較して300%超(3倍超)の血清クレアチニンの増加、または少なくとも44μmol/Lの急性的な増加を併発する血清クレアチニン≧354μmol/L、または24時間にわたる1時間あたり0.3mL/kg未満の尿量、または12時間にわたる無尿。
(i)IGFBP7(インスリン様増殖因子結合タンパク質7)の尿中濃度、(ii)組織メタロプロテアーゼ阻害物質2(TIMP−2)(tissue inhibitor of metalloproteinase 2)の尿中濃度、または(iii)IGFBP7の尿中濃度およびTIMP−2の尿中濃度の複合であるリスクスコアを、前記対象から得た尿サンプル中のIGFBP7の濃度および/またはTIMP−2の濃度を測定することにより計算して、前記リスクスコアを提供するステップと、
前記リスクスコアを、リスクスコアの閾値と比較して、前記リスクスコアが前記リスクスコアの閾値を超える場合、前記対象を、腎臓のストレスを有すると決定する、ステップと、
前記比較のステップが、前記対象が腎臓のストレスを有することを表す場合に、前記対象を、間欠的血液透析での処置と比較して少ない腎臓のストレスをもたらす腎代替療法の方法で前記対象を処置するステップと
を含む、方法に関する。
1超、好ましくは少なくとも約2以上または約0.5以下、より好ましくは少なくとも約3以上または約0.33以下、さらにより好ましくは少なくとも約4以上または約0.25以下、さらにより好ましくは少なくとも約5以上または約0.2以下、および最も好ましくは少なくとも約10以上または約0.1以下のオッズ比;
対応する、0.2超、好ましくは約0.3超、より好ましくは約0.4超、さらにより好ましくは少なくとも約0.5、さらにより好ましくは約0.6、さらにより好ましくは約0.7超、さらにより好ましくは約0.8超、より好ましくは約0.9超、および最も好ましくは約0.95の感度を伴う、0.5超、好ましくは少なくとも約0.6、より好ましくは少なくとも約0.7、さらにより好ましくは少なくとも約0.8、さらにより好ましくは少なくとも約0.9、最も好ましくは少なくとも約0.95の特異度;
対応する、0.2超、好ましくは約0.3超、より好ましくは約0.4超、さらにより好ましくは少なくとも約0.5、さらにより好ましくは約0.6、さらにより好ましくは約0.7超、さらにより好ましくは約0.8超、より好ましくは約0.9超、および最も好ましくは約0.95超の特異度を伴う、0.5超、好ましくは少なくとも約0.6、より好ましくは少なくとも約0.7、さらにより好ましくは少なくとも約0.8、さらにより好ましくは少なくとも約0.9、および最も好ましくは少なくとも約0.95の感度;
少なくとも約75%の特異度と組み合わせた少なくとも約75%の感度;
1超、少なくとも約2、より好ましくは少なくとも約3、さらにより好ましくは少なくとも約5、および最も好ましくは少なくとも約10の陽性尤度比(「感度/(1−特異度)として計算」);または
1未満、約0.5以下、より好ましくは約0.3以下、および最も好ましくは約0.1以下の陰性尤度比((1−感度)/特異度として計算)。
上記尺度のいずれかの文脈における用語「約」は、所定の測定値の±5%を表す。
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本文書の目的のため、以下の定義を適用する:
一般に、24時間の採尿が、膀胱が空となった朝から朝以降に膀胱が満たされるまで行われ、その後、比較血液試験が行われる。
持続的腎代替療法(CRRT)
持続的血液透析(CHD)
持続的動静脈血液透析(CAVHD)
持続的静静脈血液透析(CVVHD)
持続的血液濾過(CHF)
持続的動静脈血液濾過(CAVHまたはCAVHF)
持続的静静脈血液濾過(CVVHまたはCVVHF)
持続血液濾過透析(CHDF)
持続的動静脈血液濾過透析(CAVHDF)
持続的静静脈血液濾過透析(CVVHDF)
間欠的腎代替療法(IRRT)
間欠的血液透析(IHD)
間欠的静静脈血液透析(IVVHD)
間欠的血液濾過(IHF)
間欠的静静脈血液濾過(IVVHまたはIVVHF)
間欠的血液濾過透析(IHDF)。
利尿薬抵抗性肺性浮腫
高カリウム血症(医学療法に対して難治性)
代謝性アシドーシス(医学療法に対して難治性)
尿毒性合併症(心膜炎、脳症、出血)
透析可能な中毒症(たとえばリチウム、毒性アルコール、およびサリチル酸塩)。
Claims (14)
- 腎代替療法の必要のある対象の腎臓のストレスを処置するための方法であって、
(i)IGFBP7(インスリン様増殖因子結合タンパク質7)の尿中濃度、(ii)TIMP−2(組織メタロプロテアーゼ阻害物質2)の尿中濃度、または(iii)IGFBP7の尿中濃度およびTIMP−2の尿中濃度の複合、であるリスクスコアを、前記対象から得られた尿サンプル中のIGFBP7の濃度および/またはTIMP−2の濃度を測定することにより計算して、前記リスクスコアを提供するステップと、
前記リスクスコアを、リスクスコアの閾値と比較して、前記リスクスコアが前記リスクスコアの閾値を超える場合、前記対象を、腎臓のストレスを有すると決定する、ステップと、
前記比較のステップが、前記対象が腎臓のストレスを有することを表す場合に、間欠的血液透析での処置と比較して少ない腎臓のストレスをもたらす腎代替療法の方法で前記対象を処置するステップと
を含む、方法。 - 前記間欠的血液透析での処置と比較して少ない腎臓のストレスをもたらす腎代替療法の方法が、持続的腎代替療法または長期間の間欠的腎代替療法(PIRRT)である、請求項1に記載の方法。
- 前記リスクスコアを、IGFBP7の濃度およびTIMP−2の濃度の乗算により計算する、請求項1または2に記載の方法。
- 前記リスクスコアが、[TIMP−2]×[IGFBP7]/1000であり、ここでIGFBP7の濃度およびTIMP−2の濃度は、それぞれng/mLで測定される、請求項3に記載の方法。
- 前記閾値が、約2.0である、請求項4に記載の方法。
- 前記IGFBP7の尿中濃度および前記TIMP−2の尿中濃度を、前記対象から得た尿サンプルをイムノアッセイ器具に導入することにより測定し、前記イムノアッセイ器具が、固相と、前記固相の第1の位置に固定したIGFBP7抗体および前記固相の第2の位置に固定したTIMP−2抗体のうちの1つまたは両方とを含み、前記器具が、前記第1の位置および前記第2の位置のうちの1つまたは両方と前記尿サンプルを接触させ、
前記器具が、前記第1の位置に固定したIGFBP7抗体に結合するIGFBP7の量を測定し、これから前記尿サンプル中のIGFBP7の濃度を決定し、かつ/または前記器具が、前記第2の位置に固定したTIMP−2抗体に結合するTIMP−2の量を測定し、これから前記尿サンプル中のTIMP−2の濃度を決定し、
前記器具が、任意選択で、前記尿サンプル中のIGFBP7の濃度およびTIMP−2の濃度を前記リスクスコアに数学的に組み合わせ、
前記器具が、前記リスクスコアをヒトが読み取り可能な形態で記録する、
請求項1〜5のいずれか1項に記載の方法。 - 前記対象から得た尿サンプルをさらに、検出可能な標識とコンジュゲートした第2のIGFBP7抗体および検出可能な標識とコンジュゲートした第2のTIMP−2抗体と接触させ;第1のサンドイッチ複合体を、前記IGFBP7抗体、前記尿サンプルに存在するIGFBP7、および前記第2のIGFBP7抗体の間に形成し;第2のサンドイッチ複合体を、前記TIMP−2抗体、前記尿サンプルに存在するTIMP−2、および前記第2のTIMP−2抗体の間に形成し;前記IGFBP7抗体に結合するIGFBP7の量を、前記第1の位置で結合した検出可能な標識を検出する器具により決定し;前記TIMP−2抗体に結合するTIMP−2の量を、前記第2の位置で結合した検出可能な標識を検出する器具により決定する、
請求項6に記載の方法。 - 前記対象が、集中治療室の患者である、請求項1〜7のいずれか1項に記載の方法。
- 前記患者が、急性腎不全である、請求項1〜8のいずれか1項に記載の方法。
- 前記対象が、敗血症を有する、請求項1〜9のいずれか1項に記載の方法。
- 前記対象が、外科手術から回復中である、請求項1〜9のいずれか1項に記載の方法。
- 前記対象が、前記リスクスコアを提供するための尿サンプルを前記対象から得る時点で、腎代替療法を受けている、請求項1〜11のいずれか1項に記載の方法。
- 前記リスクスコアを、進行中の腎代替療法をモニタリングするために使用し、前記リスクスコアが前記閾値を超える場合、前記進行中の腎代替療法により前記対象から除去される体液量の速度または量が低減しているか、かつ/または前記進行中の腎代替療法による溶質のクリアランス速度が低減している、請求項12に記載の方法。
- 前記リスクスコアを、進行中の腎代替療法をモニタリングするために使用し、前記リスクスコアが前記閾値を超える場合、前記進行中の腎代替療法のプロトコルを、前記進行中の腎代替療法に関連する血液低下作用または用量を低減するように調節する、請求項12に記載の方法。
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