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US20090239242A1 - Method for the early identification and prediction of kidney injury - Google Patents

Method for the early identification and prediction of kidney injury Download PDF

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Publication number
US20090239242A1
US20090239242A1 US12/076,410 US7641008A US2009239242A1 US 20090239242 A1 US20090239242 A1 US 20090239242A1 US 7641008 A US7641008 A US 7641008A US 2009239242 A1 US2009239242 A1 US 2009239242A1
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United States
Prior art keywords
gst
biomarker
aki
patient
elevated
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Abandoned
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US12/076,410
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English (en)
Inventor
Cormac Gerald Kilty
Jay Lawrence Koyner
Claire Victoria McGrath
Patrick Thomas Murray
Kerstin Schuster
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Argutus Intellectual Properties Ltd
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Biotrin Intellectual Properties Ltd
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Priority to US12/076,410 priority Critical patent/US20090239242A1/en
Assigned to BIOTRIN INTELLECTUAL PROPERTIES LIMITED reassignment BIOTRIN INTELLECTUAL PROPERTIES LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MCGRATH, CLAIRE VICTORIA, KILTY, CORMAC GERARD, SCHUSTER, KERSTIN, KOYNER, JAY LAWRENCE, MURRAY, PATRICK THOMAS
Priority to EP08738147.1A priority patent/EP2255206B1/fr
Priority to PCT/IE2008/000057 priority patent/WO2009116023A1/fr
Publication of US20090239242A1 publication Critical patent/US20090239242A1/en
Assigned to ARGUTUS INTELLECTUAL PROPERTIES LIMITED reassignment ARGUTUS INTELLECTUAL PROPERTIES LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BIOTRIN INTELLECTUAL PROPERTIES LIMITED
Priority to US12/959,546 priority patent/US20110136138A1/en
Priority to US13/866,540 priority patent/US8975031B2/en
Abandoned legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/91—Transferases (2.)
    • G01N2333/9116—Transferases (2.) transferring alkyl or aryl groups other than methyl groups (2.5)
    • G01N2333/91165—Transferases (2.) transferring alkyl or aryl groups other than methyl groups (2.5) general (2.5.1)
    • G01N2333/91171—Transferases (2.) transferring alkyl or aryl groups other than methyl groups (2.5) general (2.5.1) with definite EC number (2.5.1.-)
    • G01N2333/91177—Glutathione transferases (2.5.1.18)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/34—Genitourinary disorders
    • G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy

Definitions

  • This invention relates to the early identification and prediction of kidney damage, including early identification and prediction of elevated blood creatinine levels resulting from a reduction in kidney function in a subject and, in particular, to biomarkers for the detection thereof.
  • Acute Kidney Injury is common following CT surgery occurring in 7-42% of patients (Mora Mangano, C. et al (1998) Ann Intern Med 128:194-203; and Tuttle, K. R. et al (2003) Amer J. Kid Dis 41:76-83.) Small changes in serum creatinine have been shown to correlate with increased morbidity and mortality, following CT surgery (Lassnigg, A. et al (2004) J. Am Soc Nephrol 15; 1597-1605)
  • Measurement of creatinine is the standard test in the clinic for measuring kidney function. If kidney function is abnormal, creatinine levels will increase in the blood due to decreased excretion of creatinine in the urine. Creatinine levels vary according to a person's age, size and muscle mass. In acute conditions build up of creatinine in the blood may take up to 24-72 hours to occur.
  • U.S. Publication 2004/0219603 discloses that urinary NGAL measured within two hours of cardiac surgery was predictive of Acute Renal Failure (ARF) as reflected by serum creatinine peak, which occurs several hours or even days later.
  • Acute Renal Failure Acute Renal Failure
  • GST Glutathione S-Transferase
  • the invention provides in a first aspect a method for the early identification and prediction of elevated blood creatinine levels resulting from a reduction in kidney function in a subject, which method comprises contacting a urine sample from the subject with a capture molecule for a biomarker specific for the distal region of the renal tubule and which biomarker is released from said region when there is damage to said region indicative and predictive of elevated blood creatinine levels resulting from a reduction in kidney function.
  • the method according to the invention provides a means of detecting damage to, and predicting the extent of damage to, the kidney within two hours or less of the damage occurring with the attendant advantages for the patient.
  • capture molecule herein is meant any molecule or portion thereof which binds reversibly or irreversibly to said biomarker, so that said biomarker can be detected in the urine sample.
  • the reduction in kidney function is caused by Acute Kidney Injury (AKI).
  • AKI Acute Kidney Injury
  • the AKI is caused by a condition or disease selected from age, burns, pre-existing chronic kidney disease, reduced effective arterial volume, volume depletion, nephrotic syndrome, congestive heart failure, cirrhosis, sepsis, type I diabetes, type II diabetes, obesity, inflammation, surgery, solid organ transplant, allogenic bone marrow transplant, mechanical ventilation and/or trauma.
  • a condition or disease selected from age, burns, pre-existing chronic kidney disease, reduced effective arterial volume, volume depletion, nephrotic syndrome, congestive heart failure, cirrhosis, sepsis, type I diabetes, type II diabetes, obesity, inflammation, surgery, solid organ transplant, allogenic bone marrow transplant, mechanical ventilation and/or trauma.
  • the AKI is caused by administration of a drug to the subject, including antibiotics.
  • the drug is selected from aminoglycosides, non-steroidal anti-inflammatory drugs and radiocontrast drugs.
  • the AKI may be caused by a toxin.
  • the AKI is caused by renal ischemia in a patient undergoing cardiothoracic (CT) surgery.
  • CT cardiothoracic
  • the biomarker is detectable as early as intraoperatively, allowing for immediate corrective medical intervention.
  • the method according to the invention by providing a means of detecting damage to, and predicting the extent of damage to, the kidney as early as intraoperatively represents a very significant advance in the management and treatment of patients undergoing CT surgery.
  • the biomarker is detectable in the recovery stage post CT surgery, allowing for immediate corrective medical intervention.
  • the method according to the invention by providing a means of detecting damage to, and predicting the extent of damage to, the kidney in the recovery stage post CT surgery, allows for the appropriate medical intervention to be taken, dependent on the level of the biomarker detected during the recovery stage or earlier, namely intraoperatively.
  • the method according to the invention can indicate and/or predict a reduction in kidney function significantly earlier than the current standard creatinine test or other current methods hereinabove mentioned.
  • the biomarker is detectable prior to transfer of the patient to the Intensive Care Unit (ICU).
  • ICU Intensive Care Unit
  • kidney function When the abrupt reduction in kidney function is caused by AKI, the reduction in kidney function can be reversed by managing fluid levels and other physiological parameters.
  • RRT Renal Replacement Therapy
  • the RRT will generally involve putting the patient on dialysis supplemented, as required, by managing fluid levels and other physiological parameters.
  • the biomarker is pi glutathione S transferase ( ⁇ GST), also referred to hereinafter as pi GST.
  • ⁇ GST pi glutathione S transferase
  • the biomarker is detected by immunoassay.
  • the capture molecule is preferably an antibody to ⁇ GST.
  • the antibody may be a monoclonal or a polyclonal antibody which binds to ⁇ GST.
  • the biomarker ⁇ GST can be detected using an enzyme immunoassay, more particularly an Enzyme Linked Immunosorbent Assay (ELISA).
  • ELISA Enzyme Linked Immunosorbent Assay
  • the ⁇ GST can be assayed using a commercially available kit marketed by Biotrin International Limited, Dublin, Ireland as PI GST EIA, (Catalogue No. BIO 85) which is a 96 well EIA assay format kit.
  • any other conventional assay for detecting ⁇ GST can be used.
  • the capture molecule therefor can also be a substrate or co-factor therefor.
  • the biomarker can be detected enzymatically.
  • the biomarker is detected by a point-of-care assay.
  • a point-of-care assay will typically be performed on a urine sample of less than 500 ⁇ l, typically 10 ⁇ l or less.
  • the capture medium will be suitably a dip-stick or like device having the capture molecule affixed thereto.
  • the invention also provides ⁇ GST for use as a biomarker for the early identification and prediction of elevated blood creatinine levels resulting from a reduction in kidney function.
  • a method for predicting a need for renal replacement therapy (RRT) in a patient comprising:
  • GST glutathione S transferase
  • the method may further comprise contacting a urine sample from the patient with a capture molecule for a GST isozyme.
  • the GST is ⁇ GST.
  • the GST can be detected by immunoassay and the capture molecule can be an antibody to ⁇ GST.
  • the GST can be detected enzymatically as in the case of the method hereinabove described.
  • the GST can be detected by a point-of-care assay, as hereinbefore described.
  • Elevated urinary GST concentrations can persist for days in a patient in need of RRT.
  • the elevated GST concentration in the urine can, for example, be ⁇ 30 ng/ml, ⁇ 60 ng/ml, ⁇ 70 ng/ml, ⁇ 80 ng/ml, ⁇ or 90 ng/ml or more.
  • the GST is preferably a ⁇ GST isozyme.
  • the cause of the underlying renal dysfunction in the patient for whom RRT is predicted can, for example, be such that the patient is affected by an age-related condition, burns, pre-existing chronic kidney disease, reduced effective arterial volume, volume depletion, nephrotic syndrome, congestive heart failure, cirrhosis, sepsis, type I diabetes, type II diabetes, obesity, inflammation, surgery, being a solid organ transplant recipient, being an allogenic bone marrow transplant recipient, mechanical ventilation and/or trauma or has taken or has been administered an antibiotic, drug and/or toxin.
  • an age-related condition burns, pre-existing chronic kidney disease, reduced effective arterial volume, volume depletion, nephrotic syndrome, congestive heart failure, cirrhosis, sepsis, type I diabetes, type II diabetes, obesity, inflammation, surgery, being a solid organ transplant recipient, being an allogenic bone marrow transplant recipient, mechanical ventilation and/or trauma or has taken or has been administered an antibiotic, drug and/or toxin.
  • the method according to this aspect of the invention can further comprises detecting for the presence of risk factors for RRT in the patient wherein the risk factor is selected from the group consisting of elevated serum creatinine concentration, type I diabetes, type II diabetes, hypertension, dyslipidemia, hyperglycaemia, proteinuria and hypoalbuminemia.
  • kidney function namely that which frequently occurs in a patient undergoing CT surgery.
  • the biomarker is detected earlier than 2 hours post CT surgery or earlier than two hours post Cardio-Pulmonary Bypass (CPB).
  • CPB Cardio-Pulmonary Bypass
  • the biomarker is detected at zero hours post CT surgery or CPB.
  • FIG. 1 is a graph of % change in Serum Creatinine (SCr) concentration from baseline versus time as described in Example 1;
  • FIG. 2 is a graph of absolute change in SCr concentration (mg/dl) from baseline versus time as described in Example 1;
  • FIG. 3 is a graph of ⁇ GST concentration (ng/ml) versus time as described in Example 1;
  • FIG. 4 is a graph of ⁇ GST concentration (ng/ml) versus time as described in Example 2;
  • FIG. 5 is a graph of SCr concentration as % of baseline value versus time as described in Example 2.
  • FIG. 6 is a graph of absolute change in SCr concentration from baseline (mg/dl) versus time as described in Example 2.
  • the patients were screened and approached for enrollment. The patients were excluded if they met any of the following criteria:
  • ESRD End Stage Renal Disease
  • RRT Renal Transplant
  • Serum Creatinine was measured using the Jaffe Method in a manner known per se on a Beckman Unicel DxC 600 autoanalyser (Beckman Coulter, Fullerton, Calif., USA).
  • AKI was determined by change in SCr as defined as:
  • FIG. 1 shows the percentage change in SCr from pre-operative baseline values for non-AKI patients (- ⁇ -) and AKI patients (- ⁇ -). As shown in FIG. 1 , the percentage change in SCr does not increase until after the patients have been admitted to ICU. However, as AKI is defined as an increase in SCr of 1.5 fold from baseline, detection of AKI by SCr does not occur until Day 2.
  • FIG. 2 shows the change in absolute value of SCr from pre-operative baseline values for non-AKI patients (- ⁇ -) and AKI patients (- ⁇ -). As shown in FIG. 2 , a significant increase in SCr concentration does not occur until 6 hours post ICU in AKI patients. As the definition of AKI is an absolute increase in SCr of more than or equal to 0.3 mg/dl, AKI would not be diagnosed until after 6 h Post ICU.
  • FIG. 3 shows urinary ⁇ GST levels following CT surgery for non-AKI patients (- ⁇ -) and AKI patients (- ⁇ -).
  • a significant increase in ⁇ GST concentration is observed in Post Op. This indicated that patients could be diagnosed with AKI before they are admitted to ICU.
  • an increase in ⁇ GST is observed in non-AKI patients, it is significantly lower than AKI patient ⁇ GST levels, allowing diagnosis of AKI.
  • Table 4 shows the sensitivity and specificity of ⁇ GST to detect RRT as summarised therein.
  • FIG. 4 shows the variation in urinary ⁇ GST post CT surgery for non-RRT patients (- ⁇ -) and RRT patients (- ⁇ -). It will be noted that the ⁇ GST level of RRT Patients is significantly higher than non-RRT Patients at the Post Op time point. FIG. 4 shows a concentration of 135 ng/ml is reached, which is considerably higher than AKI patients shown in FIG. 3 (75 ng/ml). This indicates severe AKI and that RRT is required.
  • FIG. 5 depicts the variation in percentage SCr from baseline post CT surgery for non-RRT patients (- ⁇ -) and RRT patients (- ⁇ -).
  • FIG. 5 shows that the percentage change of SCr above baseline is not significantly elevated above 1.5 fold increase (AKI) until Day 2. This indicates that the earliest diagnosis that RRT is required using this technique would be two days following surgery.
  • FIG. 6 shows the variation in SCr from baseline post CT surgery for non-RRT patients (- ⁇ -) and RRT patients (- ⁇ -). It will be noted from FIG. 6 that the absolute change in SCr peaked at Day 2, post surgery. At 6 h post ICU a level of 0.3 mg/dl was reached which indicates AKI. Higher concentrations of SCr were measured at Day 1 and Day 2 indicating severe AKI and a need for RRT. Using this method, RRT would not begin until one day after surgery.
  • a ⁇ GST concentration of 300%-500% relative to baseline indicates AKI.
  • a ⁇ GST concentration greater than 500% indicates severe AKI and a requirement for RRT.
  • ⁇ GST can be used to detect elevated blood creatinine, AKI and a requirement for RRT earlier than with current biomarkers used to detect an abrupt reduction in kidney function due to renal ischemia intraoperatively or post CT surgery, with the attendant advantages.

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US12/076,410 2008-03-18 2008-03-18 Method for the early identification and prediction of kidney injury Abandoned US20090239242A1 (en)

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Application Number Priority Date Filing Date Title
US12/076,410 US20090239242A1 (en) 2008-03-18 2008-03-18 Method for the early identification and prediction of kidney injury
EP08738147.1A EP2255206B1 (fr) 2008-03-18 2008-05-06 Procédé d'identification et de prédiction précoces d'une lésion rénale
PCT/IE2008/000057 WO2009116023A1 (fr) 2008-03-18 2008-05-06 Procédé d'identification et de prédiction précoces d'une lésion rénale
US12/959,546 US20110136138A1 (en) 2008-03-18 2010-12-03 Method for predicting a need for renal replacement therapy (rrt)
US13/866,540 US8975031B2 (en) 2008-03-18 2013-04-19 Method for predicting a need for renal replacement therapy (RRT)

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US20090023165A1 (en) * 2007-05-11 2009-01-22 The Institutes For Pharmaceutical Discovery, Llc Methods for Early Diagnosis of Kidney Disease
WO2012012704A2 (fr) 2010-07-23 2012-01-26 President And Fellows Of Harvard College Procédés de détection de maladies ou d'états associés au rein
WO2012012725A2 (fr) 2010-07-23 2012-01-26 President And Fellows Of Harvard College Méthodes de dépistage de maladies ou d'affections à l'aide de cellules phagocytaires
WO2012040073A3 (fr) * 2010-09-24 2012-06-14 University Of Pittsburgh -Of The Commonwealth System Of Higher Education Biomarqueurs de lésion rénale
KR101576586B1 (ko) 2013-10-08 2015-12-10 한양대학교 에리카산학협력단 신장독성 평가용 바이오마커 akr7a1 및 이를 이용한 신장독성 평가방법
US10494675B2 (en) 2013-03-09 2019-12-03 Cell Mdx, Llc Methods of detecting cancer
US10626464B2 (en) 2014-09-11 2020-04-21 Cell Mdx, Llc Methods of detecting prostate cancer
US10934588B2 (en) 2008-01-18 2021-03-02 President And Fellows Of Harvard College Methods of detecting signatures of disease or conditions in bodily fluids
US10961578B2 (en) 2010-07-23 2021-03-30 President And Fellows Of Harvard College Methods of detecting prenatal or pregnancy-related diseases or conditions
US11111537B2 (en) 2010-07-23 2021-09-07 President And Fellows Of Harvard College Methods of detecting autoimmune or immune-related diseases or conditions
US11585814B2 (en) 2013-03-09 2023-02-21 Immunis.Ai, Inc. Methods of detecting prostate cancer
EP4303584A2 (fr) 2010-07-23 2024-01-10 President and Fellows of Harvard College Procédés de détection de signatures de maladies ou pathologies dans des liquides biologiques

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WO2020064995A1 (fr) * 2018-09-28 2020-04-02 INSERM (Institut National de la Santé et de la Recherche Médicale) Utilisation de biomarqueurs représentant des voies cardiaques, vasculaires et inflammatoires permettant la prédiction d'une lésion rénale aiguë chez des patients atteints de diabète de type 2

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040219603A1 (en) * 2003-03-27 2004-11-04 Prasad Devarajan Method and kit for detecting the early onset of renal tubular cell injury

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040219603A1 (en) * 2003-03-27 2004-11-04 Prasad Devarajan Method and kit for detecting the early onset of renal tubular cell injury

Cited By (21)

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US9000134B2 (en) 2007-05-11 2015-04-07 Wallace B. Haigh Reagent and kit for early diagnosis of kidney disease
US20090023165A1 (en) * 2007-05-11 2009-01-22 The Institutes For Pharmaceutical Discovery, Llc Methods for Early Diagnosis of Kidney Disease
US11001894B2 (en) 2008-01-18 2021-05-11 President And Fellows Of Harvard College Methods of detecting signatures of disease or conditions in bodily fluids
US10934589B2 (en) 2008-01-18 2021-03-02 President And Fellows Of Harvard College Methods of detecting signatures of disease or conditions in bodily fluids
US10934588B2 (en) 2008-01-18 2021-03-02 President And Fellows Of Harvard College Methods of detecting signatures of disease or conditions in bodily fluids
US11111537B2 (en) 2010-07-23 2021-09-07 President And Fellows Of Harvard College Methods of detecting autoimmune or immune-related diseases or conditions
US10961578B2 (en) 2010-07-23 2021-03-30 President And Fellows Of Harvard College Methods of detecting prenatal or pregnancy-related diseases or conditions
EP4303584A2 (fr) 2010-07-23 2024-01-10 President and Fellows of Harvard College Procédés de détection de signatures de maladies ou pathologies dans des liquides biologiques
WO2012012704A2 (fr) 2010-07-23 2012-01-26 President And Fellows Of Harvard College Procédés de détection de maladies ou d'états associés au rein
WO2012012725A2 (fr) 2010-07-23 2012-01-26 President And Fellows Of Harvard College Méthodes de dépistage de maladies ou d'affections à l'aide de cellules phagocytaires
US10557856B2 (en) 2010-09-24 2020-02-11 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Biomarkers of renal injury
JP2013539030A (ja) * 2010-09-24 2013-10-17 ユニバーシティ オブ ピッツバーグ − オブ ザ コモンウェルス システム オブ ハイヤー エデュケイション 腎障害のバイオマーカー
WO2012040073A3 (fr) * 2010-09-24 2012-06-14 University Of Pittsburgh -Of The Commonwealth System Of Higher Education Biomarqueurs de lésion rénale
US11693014B2 (en) 2010-09-24 2023-07-04 University of Pittsburgh—of the Commonwealth System of Higher Education Biomarkers of renal injury
EA030622B1 (ru) * 2010-09-24 2018-09-28 Юниверсити Оф Питтсбург - Оф Дзе Коммонвелт Систем Оф Хайер Эдьюкейшн Способ прогнозирования восстановления функции почек
US10494675B2 (en) 2013-03-09 2019-12-03 Cell Mdx, Llc Methods of detecting cancer
US11585814B2 (en) 2013-03-09 2023-02-21 Immunis.Ai, Inc. Methods of detecting prostate cancer
US12037645B2 (en) 2013-03-09 2024-07-16 Immunis.Ai, Inc. Methods of detecting cancer
US12181477B2 (en) 2013-03-09 2024-12-31 Immunis.Ai, Inc. Methods of detecting prostate cancer
KR101576586B1 (ko) 2013-10-08 2015-12-10 한양대학교 에리카산학협력단 신장독성 평가용 바이오마커 akr7a1 및 이를 이용한 신장독성 평가방법
US10626464B2 (en) 2014-09-11 2020-04-21 Cell Mdx, Llc Methods of detecting prostate cancer

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EP2255206B1 (fr) 2015-03-11
US8975031B2 (en) 2015-03-10
WO2009116023A1 (fr) 2009-09-24
EP2255206A1 (fr) 2010-12-01
US20110136138A1 (en) 2011-06-09
US20130236908A1 (en) 2013-09-12

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Effective date: 20090921

STCB Information on status: application discontinuation

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