GDF-15 and/or troponin T for predicting kidney failure in heart surgery patients

11719,710

16/695713

November 26, 2019

The present disclosure relates to the field of laboratory diagnostics. Specifically, means and methods are disclosed for determining a patient's risk of suffering from acute kidney injury after a surgical procedure based on the detection of GDF-15, troponin T and/or a natriuretic peptide.

Roche Diagnostics Operations, Inc. (Indianapolis, IN, US)

Roche Diagnostics Operations, Inc. (Indianapolis, IN, US)

1. A method for treating a patient at risk of developing acute kidney injury (AKI) after coronary artery bypass graft (CABG) surgery, the method comprising: identifying a patient as being at high risk of developing AKI after CABG surgery, wherein the patient is identified by: (a) determining the amount of a biomarker in a plasma or serum sample from the patient which has been taken within 1 week or 2 weeks before the patient undergoes CABG surgery, wherein the biomarker comprises GDF-15 and/or Troponin; and (b) comparing the determined amount of the biomarker with a reference amount suitable for predicting whether a patient is at high risk of developing AKI after CABG surgery; wherein the amount of GDF-15 is increased compared to a reference amount of GDF-15 and/or the amount of Troponin is increased compared to a reference amount of Troponin in a patient at high risk of developing AKI; and administering a drug to the patient identified as being at high risk of developing AKI after CABG surgery.

2. The method of claim 1 , wherein the Troponin is Troponin T.

3. The method of claim 1 , wherein additionally the amount of a natriuretic peptide is determined and compared to a reference amount of the natriuretic peptide.

4. The method of claim 3 , wherein the natriuretic peptide is NT-proBNP.

5. The method of claim 1 , wherein the sample is taken within 6 hours, 12 hours or 24 hours before the surgical procedure.

6. The method of claim 1 , wherein the reference amount is an averaged median amount obtained from a group of patients before being subjected to surgery, and wherein the group of patients did not suffer from AKI after surgery.

7. The method of claim 1 , wherein the patient suffers from a cardiovascular disease.

8. The method of claim 7 , wherein the patient suffers from cardiovascular artherosclerosis.

9. The method of claim 1 , wherein the drug is erythropoietin.

5744305 April 1998 Fodor et al.
20070248989 October 2007 Devarajan
0 648 228 November 1998
1 983 345 October 2008
1983345 October 2008
WO 1999/006445 February 1999
WO 2000/070051 November 2000
WO 2002/083913 October 2002
WO 2002/089657 November 2002
WO 2005/113585 December 2005
WO 2008/060607 May 2008
WO 2009/083950 July 2009
WO 2009/141357 November 2009

Wollert et al., Clin. Chem., 2017, vol. 63(1): 140-151. cited by examiner
Wallin et al., Br. J. Cancer, 2011, vol. 104(10):1619-1627. cited by examiner
Massoudy et al., Nephrol. Dial. Transplant., 2008, vol. 23(9):2853-2860. cited by examiner
Hetland et al., Clinical Chemistry, 1998, vol. 44(6):1348-1350. cited by examiner
Giannitsis et al., “Analytical validation of a high-sensitivity cardiac troponin T assay ” Clin. Chem., 56(2):254-61 (Feb. 2010; Epub Dec. 3, 2009). cited by applicant
Cheng et al., “Wild-type p53 attenuates cancer cell motility by inducing growth differentiation factor-15 expression.” Endocrinology, 152(8):2987-95 (Aug. 2011; Epub May 17, 2011). cited by applicant
International Search Report dated May 12, 2011 in International Application No. PCT/EP2010/070058, 7 pages. cited by applicant
Bellomo, R. et al., “The pathophysiology of cardiac surgery-associates acute kidney injury (DSA-AKI)”, The International Journal of Artificial Organs, 2008, pp. 166-176, vol. 31, No. 2. cited by applicant
Brincat, Stephan and Hilton, Rachel, “Prevention of acute kidgney injury”, British Journal of Hospital Medicine, Aug. 2008, pp. 450-454, vol. 69, No. 8. cited by applicant
Ejaz et al., “Uric Acid: A Novel Risk Factor for Acute Kidney Injury in High-Risk Cardiac Surgery Patients?” American Journal of Nephrology, 2009, pp. 425-429, vol. 30. cited by applicant
Haase, et al., “Novel Biomarkers Early Predict the Severity of Acute Kidney Injury After Cardiac Surgery in Adults”, The Annals of Thoracic Surgery, 2009, pp. 124-130, vol. 88. cited by applicant
Liangos, et al., “Comparative analysis of urinary biomarkers for early detection of acute kidney injury following cariopulmonary bypass”, Biomarkers, 2009, pp. 423-431, vol. 14, No. 6. cited by applicant
Mehta, et al., “Bedside Tool for Predicting the Risk of Postoperative Dialysis in Patients Undergoing Cardiac Surgery”, Circulation, 2006, pp. 2208-2216, vol. 114. cited by applicant
Portilla, et al., “Liver fatty acid-binding protein as a biomarker of acute kidney injury after cardiac surgery”, Kidney International, 2008, pp. 465-472, vol. 73. cited by applicant
Zimmers, et al., “Growth Differentiation Factor-15/Macrophage Inhibitory Cytokine-1 Induction After Kidney and Lung Injury”, Shock, 2005, pp. 543-548, vol. 23, No. 6. cited by applicant
Abelha et al., “Determinants of postoperative acute kidney injury” Critical Care, 13(R79):10 pages (2009). cited by applicant
Anderson et al., “Molecular Basis of Human Cardiac Troponin T Isoforms Expressed in the Developing, Adult, and Failing Heart” Circulation Research, 1995, pp. 681-686, vol. 76. cited by applicant
Baek et al., “Cyclooxygenase Inhibitors Regulate the Expression of a TGF-beta Superfamily Member That has Proapoptotic and Antitumorigenic Activities” Molecular Pharmacology, 2001, pp. 901-908, vol. 59, No. 4. cited by applicant
Bartels et al., “Serum Kreatininbestimmung Ohne Enteiseissen” Clinica Chimica Acta, 1972, pp. 193-197, vol. 7, English Abstract provided. cited by applicant
Bauskin et al., “The propeptide of macrophage Inhibitory cytokine (MIC1), a TGF-B super-family member, acts as a quality control determinant for correctly folded MIC-1” EMBO 2000, pp. 2212-2220, vol. 19 No. 10. cited by applicant
Bhayana, Vipin et al., Discordance Between Results for Serum Troponin T and Troponin I in Renal Disease, Clinical Chemistry, 1995, pp. 312-317, vol. 41, No. 2. cited by applicant
Bonow, Robert O., New Insights Into the Cardiac Natriuretic Peptides, Circulation, 1996, pp. 1946-1950, vol. 93. cited by applicant
Brown, Jeremiah R. et al., Long-Term Survival After Cardiac Surgery is Predicted by Estimated Glomerular Filtration Rate, Annals of Thoracic Surgery, 2008, pp. 4-12, vol. 86. cited by applicant
Böttner, Martina et al., Characterization of the rat, mouse, and human genes of growth/differentiation factor-15/macrophage inhibiting cytokine-1 (GDF-15/MIC-1), Gene, 1999, pp. 105-111, vol. 237. cited by applicant
De Zoysa, Janak R., Cardiac troponins and renal disease, Nephrology, 2004, pp. 83-88, vol. 9. cited by applicant
Eagle, Kim A. et al., ACC/AHA Guidelines for Coronary Artery Bypass Graft Surgery A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1991 Guidelines for Coronary Artery Bypass Graft Surgery), Circulation, 2004, pp. e340-e437, vol. 110, No. 14. cited by applicant
Eagle, Kim A. et al., ACC/AHA Guidelines for Coronary Artery Bypass Graft Surgery A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1991 Guidelines for Coronary Artery Bypass Graft Surgery), Journal of the American College of Cardiology, 1999, pp. 1262-1347, vol. 14, No. 4. cited by applicant
European Search Report dated Aug. 31, 2017, in Application No. EP 17179543.8, 16 pages. cited by applicant
Ferrieres, Gaelle et al., Human cardiac troponin 1: precise identification of antigenic epitopes and prediction of secondary structure, Clinical Chemistry, 1998, pp. 487-493, vol. 44, No. 3. cited by applicant
Foster-Swanson, A. et al., Reference Interval Studies of the Rate-Blanked Creatinine/JafféMethod on BM/Hitachi Systems in Six U.S. Laboratories, Clinical Chemistry, 1994, p. 1057, Abstract 0361, vol. 40, No. 6. cited by applicant
Hanley, James A. and McNeil, Barbara J., The Meaning and Use of the Area under a Receiver Operating Characteristic (ROC) Curve, Radiology, 1982, pp. 29-36, vol. 143. cited by applicant
Hromas, Robert et al., PLAB, a novel placental bone morphogenetic protein, Biochimica et Biophysica Acta, 1997, pp. 40-44, vol. 1354. cited by applicant
Kempf, Tibor et al., The Transforming Growth Factor-β Superfamily Member Growth-Differentiation Factor-15 Protects the Heart From Ischemia/Reperfusion Injury, Circulation Research, 2006, pp. 351-360, vol. 98. cited by applicant
Lawton, Lee N. et al., Identification of a novel member of the TGF-beta superfamily highly expressed in human placenta. Gene, 1997, pp. 17-26, vol. 203. cited by applicant
Mohammed, Asim A. et al., Prospective, Comprehensive Assessment of Cardiac Troponin T Testing After Coronary Artery Bypass Graft Surgery, Circulation, 2009, pp. 843-850, vol. 120. cited by applicant
Morrish, D. W. et al., Identification by Subtractive Hybridization of a Spectrum of Novel and Unexpected Genes Associated with In Vitro Differentiation of Human Cytotrophoblast Cells, Placenta, 1996, pp. 431-441, vol. 17. cited by applicant
Mueller, Thomas et al., Long-term stability of endogenous B-type natriuretic peptide (BNP) and amino terminal proBNP (NT-proBNP) in frozen plasma samples, Clinical Chemistry & Laboratory Medicine, 2004, pp. 942-944, vol. 42, No. 8. cited by applicant
Needleman, Saul B. and Wunsch, Christian D., A General Method Applicable to the Search for Similarities in the Amino Acid Sequence of Two Proteins, Journal of Molecular Biology, 1970, pp. 443-453, vol. 48. cited by applicant
Nolan, John P. and Sklar, Larry A., Suspension array technology: evolution of the flat-array paradigm, TRENDS in Biotechnology, 2002, pp. 9-12, vol. 20, No. 1. cited by applicant
Paralkar, Vishwas M. et al., Cloning and Characterization of a Novel Member of the Transforming Growth Factor-β/Bone Morphogenetic Protein Family, The Journal of Biological Chemistry, 1998, pp. 13760-13767, vol. 273, No. 22. cited by applicant
Pearson, William R. and Lipman, David J., Improved tools for biological sequence comparison, Proceedings of the National Academy of Sciences USA, 1988, pp. 2444-2448, vol. 85. cited by applicant
Seelig, H. P. and Wüst, H., Die Kreatinbestimmung mitder JafféReaktion, Ärztliches Labor, 1969, pp. 34-39, English Summary, vol. 15. cited by applicant
Smith, M. W. et al., Delayed metabolism of human brain natriuretic peptide reflects resistance to neutral endopeptidase. Journal of Endocrinology, 2000, pp. 239-246, vol. 167. cited by applicant
Smith, Temple F. and Waterman, Michael S., Comparison of Biosequences, Advances in Applied Mathematics, 1981, pp. 482-489, vol. 2. cited by applicant
Song, Young Rim et al., Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Coronary Artery Bypass Grafting: A Pilot Study, American Journal of Nephrology, 2009, pp. 253-260, vol. 30. cited by applicant
Wu, Alan H. B. et al., Analytical and Clinical Evaluation of the Bayer ADVIA Centaur Automated B-Type Natriuretic Peptide Assay in Patients with Heart Failure: A Multisite Study, Clinical Chemistry, 2004, pp. 867-873, vol. 50, No. 5. cited by applicant
Yokoyama-Kobayashi, Midori et al., Human cDNA Encoding a Novel TGF-β Superfamily Protein Highly Expressed in Placenta, Journal of Biochemistry, 1997, pp. 622-626, vol. 122, No. 3. cited by applicant

edspgr.11719710