A guidance for renal biomarker lead optimization and use in translational pharmacodynamics

Drug Discovery Today

Volumn 15, Issue 3-4, 2010, Pages 142-147

  Ozer, Josef S ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; BETA 2 MICROGLOBULIN; BIOLOGICAL MARKER; CATHEPSIN B; CLUSTERIN; CREATININE; CYCLOSPORIN A; CYSTATIN C; GLUTATHIONE TRANSFERASE; IRBESARTAN; KIDNEY INJURY MOLECULE 1; LEUKOTRIENE C4; LEUKOTRIENE D4; LEUKOTRIENE RECEPTOR BLOCKING AGENT; LOSARTAN; N ACETYL BETA GLUCOSAMINIDASE; NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN; OSTEOPONTIN; THROMBOXANE A2 RECEPTOR BLOCKING AGENT; THROMBOXANE B2; VALSARTAN;

BILE ACID BLOOD LEVEL; CLINICAL STUDY; CLINICAL TRIAL; DIABETIC NEPHROPATHY; DRUG ANTAGONISM; DRUG APPROVAL; DRUG DESIGN; DRUG EFFICACY; GLOMERULUS FILTRATION RATE; GOOD LABORATORY PRACTICE; HEPATOBILIARY DISEASE; HISTOPATHOLOGY; HUMAN; KIDNEY BLOOD FLOW; KIDNEY DISEASE; KIDNEY FIBROSIS; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MICROALBUMINURIA; NEPHROTOXICITY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PROGNOSIS; REVIEW; SIDE EFFECT;

ALBUMINS; ANIMALS; AUTOIMMUNE DISEASES; BILE ACIDS AND SALTS; BIOMARKERS, PHARMACOLOGICAL; CATHEPSIN B; CYCLOSPORINE; CYSTATIN C; CYSTEINE; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY; LEUKOTRIENES; MODELS, ANIMAL; TRANSLATIONAL RESEARCH;

EID: 75449102360     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2009.12.001     Document Type: Review

References (35)

1. EMEA (2008) Committee for human medicinal products, final report on the pilot joint EMEA/FDA vxds experience on qualification of nephrotoxicity biomarkers. http://www.emea.europa.eu/pdfs/human/biomarkers/25088508en.pdf
2. FDA (2008) FDA, European Medicines Agency to consider additional test results When assessing new drug safety collaborative effort by FDA and EMEA expected to yield additional safety data. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116911 .htm
3. Perico N., et al. Daily renal hypoperfusion induced by cyclosporine in patients with renal transplantation. Transplantation 54 (1992) 56-60
4. Pollard S., et al. A pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A. Clin. Ther. 25 (2003) 1654-1669
5. Kasiske B.L., et al. The relationship between cyclosporine pharmacokinetic parameters and subsequent acute rejection in renal transplant recipients. Transplantation 46 (1988) 716-722
6. Kopp J.B., and Klotman P.E. Cellular and molecular mechanisms of cyclosporin nephrotoxicity. J. Am. Soc. Nephrol. 1 (1990) 162-179
7. Myers B.D., et al. Cyclosporine-associated chronic nephropathy. N. Engl. J. Med. 311 (1984) 699-705
8. Lafayette R.A., et al. The effects of blood pressure reduction on cyclosporine nephrotoxicity in the rat. J. Am. Soc. Nephrol. 3 (1993) 1892-1899
9. Ptachcinski R.J., et al. Clinical pharmacokinetics of cyclosporin. Clin. Pharmacokinet. 11 (1986) 107-132
10. Aleo M.D., et al. An underlying role for hepatobiliary dysfunction in cyclosporine A nephrotoxicity. Toxicol. Appl. Pharmacol. 230 (2008) 126-134
11. Badr K.F., et al. Renal and systemic hemodynamic responses to intravenous infusion of leukotriene C4 in the rat. Circ. Res. 54 (1984) 492-499
12. Perico N., et al. Co-participation of thromboxane A2 and leukotriene C4 and D4 in mediating cyclosporine-induced acute renal failure. Transplantation 52 (1991) 873-878
13. Butterly D.W., et al. A role for leukotrienes in cyclosporine nephrotoxicity. Kidney Int. 57 (2000) 2586-2593
14. Benigni A., et al. Increased urinary excretion of thromboxane B2 and 2,3-dinor-TxB2 in cyclosporin A nephrotoxicity. Kidney Int. 34 (1988) 164-174
15. Duane W.C., et al. Effects of fasting on bile acid metabolism and biliary lipid composition in man. J. Lipid Res. 17 (1976) 211-219
16. Huber M., et al. Metabolism of cysteinyl leukotrienes in monkey and man. Eur. J. Biochem. 194 (1990) 309-315
17. Laidlaw S.A., et al. Patterns of fasting plasma amino acid levels in chronic renal insufficiency: results from the feasibility phase of the Modification of Diet in Renal Disease Study. Am. J. Kidney Dis. 23 (1994) 504-513
18. Tucholska M., et al. Human serum proteins fractionated by preparative partition chromatography prior to LC-ESI-MS/MS. J. Proteome Res. 8 (2009) 1143-1155
19. Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat. Rev. Drug Discov. 4 (2005) 489-499
20. Lee W.M. Drug-induced hepatotoxicity. N. Engl. J. Med. 349 (2003) 474-485
21. Basi S., et al. Microalbuminuria in type 2 diabetes and hypertension: a marker, treatment target, or innocent bystander?. Diabetes Care 31 Suppl. 2 (2008) S194-S201
22. Schiffrin E.L., et al. Chronic kidney disease: effects on the cardiovascular system. Circulation 116 (2007) 85-97
23. Meinhardt U., et al. Microalbuminuria in diabetes mellitus: efficacy of a new screening method in comparison with timed overnight urine collection. J. Diabetes Complications 17 (2003) 254-257
24. Ruggenenti P., and Remuzzi G. Time to abandon microalbuminuria?. Kidney Int. 70 (2006) 1214-1222
25. Atkins R.C., et al. Proteinuria reduction and progression to renal failure in patients with type 2 diabetes mellitus and overt nephropathy. Am. J. Kidney Dis. 45 (2005) 281-287
26. de Zeeuw D., et al. Proteinuria, a target for renoprotection in patients with type 2 diabetic nephropathy: lessons from RENAAL. Kidney Int. 65 (2004) 2309-2320
27. Jerums G., et al. New and old markers of progression of diabetic nephropathy. Diabetes Res. Clin. Pract. 82 Suppl. 1 (2008) S30-S37
28. Tsalamandris C., et al. Progressive decline in renal function in diabetic patients with and without albuminuria. Diabetes 43 (1994) 649-655
29. Rigalleau V., et al. Normoalbuminuric renal-insufficient diabetic patients: a lower-risk group. Diabetes Care 30 (2007) 2034-2039
30. Schaefer L., et al. Urinary excretion of cathepsin B and cystatins as parameters of tubular damage. Kidney Int. Suppl. 47 (1994) S64-S67
31. Piwowar A., et al. Urinary activities of cathepsin B, N-acetyl-beta-d-glucosaminidase, and albuminuria in patients with type 2 diabetes mellitus. Med. Sci. Monit. 12 (2006) CR210-CR214
32. Salem M.A., et al. Urinary excretion of n-acetyl-beta-d-glucosaminidase and retinol binding protein as alternative indicators of nephropathy in patients with type 1 diabetes mellitus. Pediatr. Diabetes 3 (2002) 37-41
33. Tidman M., et al. A comparison of GFR estimating formulae based upon s-cystatin C and s-creatinine and a combination of the two. Nephrol. Dial. Transplant. 23 (2008) 154-160
34. Christensson A.G., et al. Serum cystatin C advantageous compared with serum creatinine in the detection of mild but not severe diabetic nephropathy. J. Intern. Med. 256 (2004) 510-518
35. Ozer J.S., and Teitelbaum A. Novel prodromal biomarkers that are symptomatic of injury require histopathologic or clinical chemistry anchors to characterize activity. J. Pharmacol. Toxicol. Methods 60 (2009) 321-322