IGFBP7 for prediction of risk of AKI when measured prior to surgery

Patent metadata

Field	Value
Publication number	US-11397187-B2
Application number	US-201815943104-A
Country	US
Kind code	B2
Filing date	Apr 2, 2018
Priority date	Oct 8, 2015
Publication date	Jul 26, 2022
Grant date	Jul 26, 2022

Abstract

The present disclosure describes a method for predicting the risk of a patient to suffer from acute kidney injury (AKI) during or after a surgical procedure or after administration of a contrast medium. The method is based on the determination of the level of the biomarker IGFBP7 (Insulin-like Growth Factor Binding Protein 7) in a body fluid sample obtained from the patient prior to the surgical procedure or prior to the administration of a contrast medium. Further, the present disclosure describes a method for predicting the risk of a patient to suffer from acute kidney injury (AKI) based on the determination of the amount of the biomarker IGFBP7 (Insulin-like Growth Factor Binding Protein 7) and Cystatin C in a body fluid sample obtained from the patient. The present disclosure further encompasses kits and devices adapted to carry out the methods of the disclosed methods.

First claim

The invention claimed is:

1. A method for identifying a patient not at risk to suffer from acute kidney injury (AKI) during or after a surgical procedure or not at risk to suffer from acute kidney injury (AKI) after administration of a contrast medium and subjecting the identified patient to the surgical procedure or administering the contrast medium to the identified subject, comprising the steps of:
(a) combining a blood, serum or plasma sample obtained from a patient prior to a surgical procedure or prior to administration of a contrast medium with an antibody specific for IGFBP7 (Insulin-like Growth Factor Binding Protein 7);
(b) determining the amount of the biomarker IGFBP7 (Insulin-like Growth Factor Binding Protein 7) in the blood, serum or plasma sample obtained from the patient prior to the surgical procedure or prior to the administration of a contrast medium;
(c) comparing the determined amount of said biomarker to a reference, wherein said reference is an amount of IGFBP7 in a patient or group of patients known to have suffered from acute kidney injury after a surgical procedure or after administration of a contrast medium;
(d) identifying that the patient is not at risk of suffering from acute kidney injury during or after a surgical procedure or after administration of a contrast medium when the determined amount of IGFBP7 is below the reference; and
(e) subjecting the identified patient to the surgical procedure or administering the contrast medium to the identified subject.

2. The method of claim 1 , wherein said patient is a human patient.

3. The method of claim 1 , wherein the patient is not an intensive care unit patient at the time at which the sample is obtained.

4. The method of claim 1 , wherein the sample has been obtained within four weeks prior to said surgical procedure or the administration of the contrast medium.

5. The method of claim 1 , wherein said reference is a predetermined value.

6. The method of claim 1 , further comprising the determination of the amount of at least one additional biomarker selected from the group of Cystatin C, L-FABP (liver-type fatty acid binding protein), Osteopontin, IL-6 (Interleukin 6), NGAL, GDF-15 (Growth Differentiation Factor 15), Creatinine, a cardiac Troponin and a BNP-type peptide.

7. The method of claim 1 , wherein the patient is suffering from chronic kidney disease.

8. The method of claim 1 , wherein said surgical procedure is a surgery that involves general anesthesia, and/or mechanical ventilation.

9. The method of claim 1 , wherein said surgical procedure is cardiac surgery.

10. The method of claim 1 , wherein the sample has been obtained within one week prior to said surgical procedure or the administration of the contrast medium.

11. The method of claim 1 , wherein the sample has been obtained within three days prior to said surgical procedure or the administration of the contrast medium.

12. The method of claim 1 , wherein the sample has been obtained within 12 hours prior to said surgical procedure or the administration of the contrast medium.

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Horsch Andrea
• Klapperich Birgit
• Block Dirk
• Engel Alfred
• Karl Johann
• Kientsch-Engel Rosemarie
• Manuilova Ekaterina
• Rabe Christina
• Rutz Sandra
• Soukupova Monika
• Wienhues-Thelen Ursula-Henrike
• Kastner Peter
• Kaiser Edelgard Anna

Classifications

• G01N2333/47

  Assays involving proteins of known structure or function as defined in the subgroups · CPC title

• G01N33/74

  involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors} · CPC title

• G01N2800/50

  Determining the risk of developing a disease · CPC title

• G01N2333/8139

  Cysteine protease (E.C. 3.4.22) inhibitors, e.g. cystatin · CPC title

• G01N33/6893 Primary

  related to diseases not provided for elsewhere · CPC title