JP6681195B2 - 腎損傷および腎不全の診断および予後診断のための方法ならびに組成物 - Google Patents
腎損傷および腎不全の診断および予後診断のための方法ならびに組成物 Download PDFInfo
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- 238000000108 ultra-filtration Methods 0.000 description 1
- 238000011547 urine creatinine measurement Methods 0.000 description 1
- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 description 1
- 102000009816 urokinase plasminogen activator receptor activity proteins Human genes 0.000 description 1
- 108040001269 urokinase plasminogen activator receptor activity proteins Proteins 0.000 description 1
- 230000006496 vascular abnormality Effects 0.000 description 1
- 230000009723 vascular congestion Effects 0.000 description 1
- 230000025033 vasoconstriction Effects 0.000 description 1
- 235000012431 wafers Nutrition 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000001262 western blot Methods 0.000 description 1
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Description
「リスク」:ベースラインから1.5倍の血清クレアチニンの増加、または6時間の間の、0.5ml/体重kg/時間より少ない尿の産生;
「損傷」:ベースラインから2.0倍の血清クレアチニンの増加、または12時間の間の、0.5ml/体重kg/時間より少ない尿の産生;
「不全」:ベースラインから3.0倍の血清クレアチニンの増加もしくは355μmol/lを超えるクレアチニン(44を超える上昇)、または24時間の間の、0.3ml/kg/hrを下回る尿排出量または少なくとも12時間の間、無尿;
かつ2つの臨床予後を含む:
「喪失」:4週間を超える腎置換療法の永続的な必要性:
「ESRD」:末期の腎疾患−3ヶ月を超える透析の必要性:
さらに最近、Mehta et al.,Crit.Care 11:R31(doi:10.1186.cc5713),2007(これは、参照によりその全体が本明細書に組込まれる)が、RIFLEから変更された、AKI患者を層別化するための以下の類似の分類を提議している。
「ステージI」:0.3mg/dL以上(≧26.4μmol/L以上)の血清クレアチニンの増加もしくはベースラインから150%(1.5倍)以上の増加、または6時間以上の間の、1時間あたり0.5mL/kgより少ない尿排出量;
「ステージII」:ベースラインから200%(2倍)を超える血清クレアチニンの増加、または12時間以上の間の、1時間あたり0.5mL/kgより少ない尿排出量;
「ステージIII」:ベースラインから300%(3倍)を超える血清クレアチニンの増加、または少なくとも44μmol/Lの急激な増加を伴う354μmol/L以上の血清クレアチニン、または24時間の間の、1時間あたり0.3mL/kgより少ない尿排出量、もしくは12時間の間、無尿。
1を超える、好ましくは少なくとも約2以上もしくは約0.5以下、より好ましくは少なくとも約3以上もしくは約0.33以下、さらにより好ましくは少なくとも約4以上もしくは約0.25以下、さらにより好ましくは少なくとも約5以上もしくは約0.2以下、最も好ましくは少なくとも約10以上もしくは0.1以下のオッズ比;
0.5を超える、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0.9、最も好ましくは少なくとも0.95の特異度、および0.2を超える、好ましくは約0.3を超える、より好ましくは約0.4を超える、さらにより好ましくは少なくとも約0.5を超える、さらにより好ましくは約0.6を超える、さらにより好ましくは約0.7を超える、さらにより好ましくは約0.8を超える、より好ましくは約0.9を超える、最も好ましくは約0.95を超える対応する感度;
0.5を超える、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0.9、最も好ましくは少なくとも0.95の感度、および0.2を超える、好ましくは約0.3を超える、より好ましくは約0.4を超える、さらにより好ましくは少なくとも約0.5を超える、さらにより好ましくは約0.6を超える、さらにより好ましくは約0.7を超える、さらにより好ましくは約0.8を超える、より好ましくは約0.9を超える、最も好ましくは約0.95を超える対応する特異度;
少なくとも約75%の感度および少なくとも約75%の特異度;
1を超える、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、最も好ましくは少なくとも約10の(感度/(1−特異度)として計算される)陽性尤度比;または
1より低い、約0.5以下、より好ましくは約0.3以下、最も好ましくは約0.1以下の((1−感度)/特異度として計算される)陰性尤度比。
上記の尺度のいずれかの文脈における「約」という用語は、既定の尺度の+/−5%を表す。
一般に、イムノアッセイは、所望のバイオマーカーを含むまたは含むと思われる試料と、このバイオマーカーと特異的に結合する少なくとも1種類の抗体とを接触させるステップを含む。その後、この試料中のポリペプチドとこの抗体が結合することにより形成される複合体の存在または量を示すシグナルが発生する。その後、このシグナルは、この試料中のバイオマーカーの存在または量と関連する。バイオマーカーの検出および解析のための多数の方法および装置が当業者に周知である。例えば、米国特許第6,143,576号、同第6,113,855号、同第6,019,944号、同第5,985,579号、同第5,947,124号、同第5,939,272号、同第5,922,615号、同第5,885,527号、同第5,851,776号、同第5,824,799号、同第5,679,526号、同第5,525,524号、および同第5,480,792号明細書、ならびにThe Immunoassay Handbook,David Wild,ed.Stockton Press,New York,1994を参照されたい。これらの各々は、全ての表、図および特許請求の範囲を含めて、参照によりその全体が本明細書に組込まれる。
本明細書で使用する「抗体」という用語は、抗原またはエピトープと特異的に結合することができる免疫グロブリン遺伝子もしくは複数の免疫グロブリン遺伝子、もしくはその断片に由来する、それらを手本にするまたはそれらによって実質的にコードされるペプチドもしくはポリペプチドを表す。例えば、Fundamental Immunology,3rd Edition,W.E.Paul,ed.,Raven Press,N.Y.(1993);Wilson(1994;J.Immunol.Methods 175:267−273;Yarmush(1992)J.Biochem.Biophys.Methods 25:85−97を参照されたい。抗体という用語は,抗原に結合する能力を保有する抗原結合部分、すなわち「抗原結合部位」(例えば、断片、サブシーケンス、相補性決定領域(CDR))を含み、(i)VL、VH、CLおよびCH1ドメインからなる一価の断片であるFab断片;(ii)ヒンジ領域においてジスルフィド架橋によって結合される2つのFab断片からなる二価の断片であるF(ab’)2断片;(iii)VHおよびCH1ドメインからなるFd断片;(iv)抗体の単一アームのVLおよびVHドメインからなるFv断片;(v)VHドメインからなるdAb断片(Ward et al.,(1989) Nature 341:544−546)ならびに(vi)単離された相補性決定領域(CDR)を含む。一本鎖抗体も、参照により「抗体」という用語に含まれる。
バイオマーカーの使用に関して本明細書で使用する「相関する」という用語は、患者におけるバイオマーカー(複数可)の存在または量を、ある病気を患っていると知られている、もしくはある病気を患うリスクのあることが知られているヒト、またはある病気にかかっていないことが知られているヒトにおけるその存在または量とを比較することを表す。多くの場合、これは、バイオマーカー濃度の形式のアッセイ結果と、疾患の発生もしくは不発生またはある将来的な予後の可能性を示すと選択される所定の閾値とを比較する形式をとる。
上記のように、本明細書で使用する「急性腎(または腎臓)損傷」および「急性腎(または腎臓)不全」という用語を、ベースラインの値からの血清クレアチニンの変化に関して、ある程度定義する。ARFのほとんどの定義は、血清クレアチニンおよび、多くの場合、尿排出量の使用を含む共通事項を有する。この比較において使用する腎機能の利用できるベースラインを測定することなく、腎機能障害を有する患者が存在し得る。かかる事象において、最初に、患者が正常なGFRを有すると想定することにより、ベースラインの血清クレアチニンの値を推定することができる。糸球体濾過量(GFR)は、単位時間あたりの腎(腎臓)糸球体毛細血管からボーマン嚢に濾過される液体の体積である。血液中に安定したレベルで存在し、腎臓によって自由に濾過されるが、再吸収または分泌のいずれも起こらない任意の化学物質を測定することにより、糸球体濾過量(GFR)を計算することができる。典型的には、GFRをml/分の単位で表す。
一度診断が確立すると、腎置換療法の開始、腎臓に損傷をあたえると知られる化合物送達の取りやめ、腎臓移植、腎臓に損傷をあたえることが知られる処置の遅延または回避、改良された利尿薬の投与、目標指向の治療の開始などのその診断に適合する治療計画を、臨床医は容易に選択することができる。当業者は、本明細書記載の診断法に関して論じられる多数の疾患の適切な治療を知っている。例えば、Merck Manual の Diagnosis and Therapy,17th Ed.Merck Research Laboratories,Whitehouse Station,NJ,1999を参照されたい。さらに、本明細書記載の方法および組成物は予後の情報を提供するので、本発明のマーカーを用いて、治療経過を監視することが可能である。例えば、予後の状態の改善または悪化は、特定の治療が有効であるかまたは有効ではないかを示し得る。
実施例1
造影剤腎症試料の収集
この資料収集研究の目的は、血管内への造影剤の投入前後の、患者の血漿および尿の試料ならびに臨床データを収集することである。ヨウ素造影剤の血管内投与を含むX線検査/血管造影検査を行う約250人の成人を登録する。この研究に登録するためには、それぞれの患者は以下の試験対象患者基準の全てを満たさなければならず、かつ以下の試験対象除外基準のいずれも満たしてはいけない:
試験対象患者基準
18歳以上の男性および女性であること;
造影剤の血管内投与を含む(CTスキャンまたは冠状動脈インターベンションなどの)X線検査/血管造影検査を行うこと;
造影剤投与後少なくとも48時間の間は入院することが期待されること;
研究の参加について書面によるインフォームド・コンセントを提出すること、かつ全ての研究手順に従うことができ、かつその意思があること。
試験対象除外基準
腎移植者であること;
造影の手順に先立って、急に腎機能が悪化すること;
(緊急のまたは習慣的に)透析をすでに受けているか、または登録時に透析の切迫した必要性があること;
造影剤投与後48時間以内に、(例えば、心肺バイパスを含む)大手術、またはさらなる腎損傷のかなりのリスクを有する造影剤による追加の画像診断手順を行うことが期待されること;
試験前30日以内に実験的治療を伴う介入的臨床研究に参加すること;
ヒト免疫不全ウイルス(HIV)または肝炎ウイルスによる感染が判明していること。
心臓外科試料の収集
この資料収集研究の目的は、心臓血管手術(腎臓機能に潜在的に損傷を与えると知られる手術)を受ける前後の、患者の血漿および尿の試料ならびに臨床データを収集することである。かかる手術を受ける約900人の成人を登録する。この研究に登録するためには、それぞれの患者は以下の試験対象患者基準の全てを満たさなければならず、かつ以下の試験対象除外基準のいずれも満たしてはいけない:
試験対象患者基準
18歳以上の男性および女性であること;
心臓血管手術を行うこと;
腎置換リスクスコアのToronto/Ottawa Predictive Risk Index(Wijeysundera et al.,JAMA 297:1801−9,2007)が少なくとも2であること;および
研究の参加について書面によるインフォームド・コンセントを提出すること、かつ全ての研究手順に従うことができ、かつその意思があること。
試験対象除外基準
妊娠が判明していること;
腎移植の前歴があること;
登録に先立って、急に腎機能が悪化すること(例えば、RIFLE分類のいずれかのカテゴリー);
(緊急のまたは習慣的に)透析をすでに受けているか、または登録時に透析の切迫した必要性があること:
AKIのための薬剤注入もしくは治療的介入を伴う心臓手術後7日以内に、別の臨床研究にすぐに登録するか、または別の臨床研究に登録することが期待されること;
ヒト免疫不全ウイルス(HIV)または肝炎ウイルスによる感染が判明していること。
急性疾患の対象の試料の収集
この研究の目的は、急性疾患の患者の試料を収集することである。少なくとも48時間の間、ICUにいることが期待される約1900人の成人を登録する。この研究に登録するためには、それぞれの患者は以下の試験対象患者基準の全てを満たさなければならず、かつ以下の試験対象除外基準のいずれも満たしてはいけない:
試験対象患者基準
18歳以上の男性および女性であること;
研究集団1:以下の少なくとも1つを有する約300人の患者:
ショック状態(90mmHg未満のSBPおよび /または60mmHgを超えるMAPを維持するために昇圧剤のサポートの必要性および/または少なくとも40mmHgのSBPの文書化された急降下);ならびに
敗血症;
研究集団2:以下の少なくとも1つを有する約300人の患者:
登録の24時間以内に医師向けコンピューター受注システム(CPOE)で注文したIV構成物質;
登録の24時間以内の造影剤の曝露;
急性非代償性心不全を伴う腹圧の増加;ならびに
登録後48時間の間のICU入院およびICUに入院する可能性の主な理由として重症外傷;
研究集団3:約300人の患者急性腎損傷(例えば、敗血症、低血圧症/ショック状態(ショック=90mmHg未満の収縮期のBPおよび/もしくは60mmHgを超えるMAPを維持するために昇圧剤のサポートの必要性および/もしくは40mmHgを超えるSBPの文書化された急降下)、大外傷、大出血、または大手術)のリスクファクターが判明することで救急処置の環境(ICUまたはED)を経て入院し、かつ/または登録後少なくとも24時間ICUに入院することが期待されること;
研究集団4:ICUに入院してから24時間以内の21歳以上の約1000人の患者
登録後少なくとも48時間留置導尿カテーテルを有すること、および登録前24時間以内に以下の急性の条件の少なくとも1つを有することが期待されること:
(i)2より大きい呼吸器のSのAスコア(PaO2/FiO2<300)、(ii)1より大きい心血管系SのAスコア(MAP<70mm、Hgおよび/または任意の昇圧剤が必要とされる)
試験対象除外基準
妊娠が判明していること;
施設居住者;
腎移植の前歴があること;
登録に先立って、腎機能の急激な悪化が判明していること(例えば、RIFLE判定基準のいずれかのカテゴリー);
登録前5日以内に(緊急のまたは習慣的に)透析を受けたか、または登録時に透析の切迫した必要性があること:
ヒト免疫不全ウイルス(HIV)または肝炎ウイルスによる感染が判明していること;
以下のいずれかを満たすこと;
(i)一日で4単位より大きいPRBCの必要性が期待される活性出血;
(ii)ヘモグロビン7g/dL未満;
(iii)医師の意見において、臨床研究の目的のために連続して血液試料を引き出すのが禁忌だとされるその他の条件;
上記の試験対象患者基準の90mmHg未満のSBPのみを満たし、主治医または研究責任者の意見にショックを受けないこと;
イムノアッセイ形式
標準的なサンドイッチ酵素イムノアッセイ技術を用いて、検体を測定する。検体と結合する一次抗体を、ニトロセルロース試験のストリップにおいて固定化した。検体と結合する蛍光性結合型二次抗体を試験試料に添加し、この混合物を側流の形式のニトロセルロースストリップを横切らせ、それによって、この検体(存在する場合)および一次抗体とでサンドイッチ複合体を形成させる。試料中に存在する検体の量に比例する蛍光性を、蛍光光度計を使用して検出した。検体標準物質から作成した標準曲線と比較することにより、検体濃度をこの試験試料に割り当てた。
外見上健康そうである提供者および慢性疾患患者の試料
慢性または急性疾患が判明していない提供者(「外見上健康そうである提供者」)のヒトの尿試料を2社(Golden West Biologicals,Inc.,27625 Commerce Center Dr.,Temecula,CA 92590およびVirginia Medical Research,Inc.,915 First Colonial Rd.,Virginia Beach,VA 23454)から購入した。これらの尿試料を輸送し、−20℃より低い温度で凍結保存した。これらの会社が、性別、人種(白人/黒人)、喫煙状態および年齢を含む個々の提供者の人口学的情報を提供した。
患者の腎臓の状態を評価するための腎臓損傷マーカーの使用
集中治療室(ICU)の患者を以下の試験において登録した。それぞれの患者をRIFLE判定基準によって決定するように、登録後7日以内に達した最高ステージに従って、損傷なし(0)、損傷のリスク(R)、損傷(I)、および不全(F)として腎臓状態によって分類した。EDTA抗凝固処理血液試料(10mL)、血清血液試料(3mL)、および尿試料(25〜30mL)を登録時、造影剤投与してから4(±0.5)および8(±1)時間後(該当する場合)、登録後12(±1)、24(±2)、36(±2)および48(±2)、60(±2)、72(±2)、および84(±2)時間の時点、その後、対象が入院していた間毎日、最高7日〜14日目までそれぞれの患者から収集した。インシュリン様増殖因子‐結合タンパク質7およびメタロプロテイナーゼ阻害剤2を、尿試料中において、NephroCheck試験(Astute Medical, Inc., カリフォルニア州サンディエゴ)によりそれぞれ測定した。ヤッフェ反応に基づく方法を使用して、クレアチニン解析用の独立した研究室に血清試料を届けた。血清クレアチニンを、以下の表におけるmg/dLの単位で記録した。尿流量および患者の重量を臨床段階で記録した。重量調節した尿排出量を、試料収集の時間、mL/kg/時間の単位で記録した。
Claims (10)
- 対象の将来的な急性腎不全(ARF)の可能性を評価する方法であって、
尿中TIMP2の濃度および尿中IGFBP7の濃度のうちの1つ以上の測定値をイムノアッセイにより決定することと、
血清クレアチニン濃度および尿排出量のうちの1つ以上の測定値を決定することと、
入手した前記測定値を併せて単一の値としアッセイ結果を提供することであって、ここで前記単一の値が、尿中TIMP2×尿中IGFBP7×血清クレアチニン;尿中TIMP2×尿中IGFBP7/尿排出量;尿中TIMP2×尿中IGFBP7×血清クレアチニン/尿排出量;尿中TIMP2×血清クレアチニン;尿中TIMP2/尿排出量;尿中TIMP2×血清クレアチニン/尿排出量;尿中IGFBP7×血清クレアチニン;尿中IGFBP7/尿排出量;または尿中IGFBP7×血清クレアチニン/尿排出量として計算されることと、
前記単一の値と前記対象の将来的な急性腎不全の可能性とを相関させることを含み、
前記相関させることが、
(i)前記単一の値又はそれに由来する数値を受信者動作特性(ROC)解析を用いて決定した閾値と比較するステップであって、前記閾値は、対象集団を前記単一の値又はそれに由来する数値が前記閾値を上回る第一のコホートと、前記単一の値又はそれに由来する数値が前記閾値を下回る第二のコホートに分けるために選択され、ここで第一のコホートは第二のコホートより急性腎不全に罹患するより高い危険性があることを特徴とするステップ、および
(ii)前記単一の値又はそれに由来する数値が前記閾値を上回る場合に、将来的に急性腎不全を蒙る可能性増大を前記対象に割り当てるステップ、または、前記単一の値又はそれに由来する数値が前記閾値を下回る場合に、将来的に急性腎不全を蒙る可能性低減を前記対象に割り当てるステップを含み、
前記将来的な急性腎不全の可能性とは、体液試料を前記対象から入手する時点から48時間または24時間内に急性腎不全が生じ得るということである、方法、において使用するための、TIMP2と特異的に結合する抗体およびIGFBP7と特異的に結合する抗体からなる群から選択される1つ以上の試薬を含むキット。 - 鬱血性心不全、子癇前症、子癇、真性糖尿病、高血圧、冠動脈疾患、タンパク尿、腎不全、正常範囲を下回る糸球体濾過、肝硬変、正常範囲を上回る血清クレアチニン、敗血症、腎機能への損傷、腎機能の低下、もしくはARFのうちの1つ以上の現在の診断に基づいて、または大規模な血管手術、冠動脈バイパス、もしくは他の心臓手術を経験するもしくは経験したことに基づいて、またはNSAID、シクロスポリン、タクロリムス、アミノグリコシド、フォスカネット、エチレングリコール、ヘモグロビン、ミオグロビン、イホスファミド、重金属、メトトレキサート、放射線造影剤、もしくはストレプトゾトシンへの曝露に基づいて将来的な急性腎不全の可能性を評価するために前記対象が選択される、請求項1に記載のキット。
- 前記相関させることが、前記アッセイ結果に基づいて、腎機能への損傷、腎機能の低下、もしくはARFを患っている対象において腎機能が改善しているか、または悪化しているか否かを評価することを含む、請求項1に記載のキット。
- 前記対象がRIFLEステージ0またはRにいる、請求項1〜3のいずれか1項に記載のキット。
- 前記対象がRIFLEステージ0におり、かつ前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージR、IまたはFに達する可能性を割り当てることを含むか、
前記対象がRIFLEステージ0におり、前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージIまたはFに達する可能性を割り当てることを含むか、
前記対象がRIFLEステージ0におり、前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージFに達する可能性を割り当てることを含むか、
前記対象がRIFLEステージ0またはRにおり、前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージIまたはFに達する可能性を割り当てることを含むか、
前記対象がRIFLEステージ0またはRにおり、前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージFに達する可能性を割り当てることを含むか、
前記対象がRIFLEステージRにおり、前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージIまたはFに達する可能性を割り当てることを含むか、または、
前記対象がRIFLEステージRにおり、前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージFに達する可能性を割り当てることを含む、請求項4に記載のキット。 - 前記対象がRIFLEステージ0、R、またはIにおり、かつ前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージFに達する可能性を割り当てることを含む、請求項1に記載のキット。
- 前記対象がRIFLEステージIにおり、かつ前記相関させることが、前記対象が48時間以内、又は24時間以内にRIFLEステージFに達する可能性を割り当てることを含む、請求項6に記載のキット。
- 前記対象が急性腎不全ではないか、
前記対象が、前記体液試料が取得される時点の前に決定されるベースライン値から1.5倍以上の血清クレアチニンの増加を経験したことがないか、
前記対象の尿排出量が、前記体液試料が取得される時点に先立つ6時間にわたって、少なくとも0.5ml/kg/時であるか、
前記対象が、前記体液試料が取得される時点の前に決定されるベースライン値から0.3mg/dL以上の血清クレアチニンの増加を経験したことがないか、
前記対象が、(i)前記体液試料が取得される時点の前に決定されるベースライン値から1.5倍以上の血清クレアチニンの増加を経験したことがなく、(ii)尿排出量が、前記体液試料が取得される時点に先立つ6時間にわたって、少なくとも0.5ml/kg/時であり、かつ(iii)前記体液試料が取得される時点の前に決定されるベースライン値から0.3mg/dL以上の血清クレアチニンの増加を経験したことがないか、
前記相関させることが、48時間以内に前記対象は(i)1.5倍以上の血清クレアチニンの増加を経験するか、(ii)尿排出量が6時間にわたって0.5ml/kg/時未満であるか、または(iii)0.3mg/dL以上の血清クレアチニンの増加を経験するという可能性のうちの1つ以上を割り当てることを含むか、または、
前記相関させることが、24時間以内に前記対象は(i)1.5倍以上の血清クレアチニンの増加を経験するか、(ii)尿排出量が6時間にわたって0.5ml/kg/時未満であるか、または(iii)0.3mg/dL以上の血清クレアチニンの増加を経験するという可能性のうちの1つ以上を割り当てることを含む、請求項1に記載のキット。 - 前記対象が、前記体液試料が取得される時点の前に決定されるベースライン値から2倍以上の血清クレアチニンの増加を経験したことがないか、
前記対象の尿排出量が、前記体液試料が取得される時点に先立つ12時間にわたって、少なくとも0.5ml/kg/時であるか、
前記相関させることが、48時間以内に前記対象は2倍以上の血清クレアチニンの増加を経験するという可能性を割り当てることを含むか、
前記相関させることが、48時間以内に前記対象の尿排出量は12時間にわたって0.5ml/kg/時未満であるという可能性を割り当てることを含むか、
前記相関させることが、24時間以内に前記対象は2倍以上の血清クレアチニンの増加を経験するという可能性を割り当てることを含むか、または、
前記相関させることが、24時間以内に前記対象の尿排出量は12時間にわたって0.5ml/kg/時未満であるという可能性を割り当てることを含む、請求項1に記載のキット。 - 前記相関させることが、48時間以内に前記対象は(i)3倍以上の血清クレアチニンの増加を経験するか、または(ii)尿排出量が24時間にわたって0.3ml/kg/時未満であるか、もしくは12時間にわたって無尿であるという可能性のうちの1つ以上を割り当てることを含むか、または、
前記相関させることが、24時間以内に前記対象は(i)3倍以上の血清クレアチニンの増加を経験するか、または(ii)尿排出量が24時間にわたって0.3ml/kg/時未満であるか、もしくは12時間にわたって無尿であるという可能性のうちの1つ以上を割り当てることを含む、請求項1に記載のキット。
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