Detection and management of nephrotoxicity during drug development

Expert Opinion on Drug Safety

Volumn 11, Issue 4, 2012, Pages 581-596

  Loghman Adham, Mahmoud ^a   Kiu Weber, Chek Ing ^b   Ciorciaro, Cornelia ^b   Mann, Jessica ^b   Meier, Matthias ^b  

^a HOFFMANN LA ROCHE INC   (United States)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

AKIN; Biomarkers; Creatinine; Drug induced nephrotoxicity; Nephrotoxicity; RIFLE

Indexed keywords

ALBUMIN; AMPHOTERICIN B; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; BETA 2 MICROGLOBULIN; BIOLOGICAL MARKER; CALCINEURIN INHIBITOR; CLUSTERIN; CONTRAST MEDIUM; CYCLOSPORIN; CYSTATIN C; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; EPLERENONE; KIDNEY INJURY MOLECULE 1; NONSTEROID ANTIINFLAMMATORY AGENT; PENTAMIDINE; SPIRONOLACTONE; TACROLIMUS; TRIMETHOPRIM;

ACUTE KIDNEY FAILURE; CHILD CARE; CHRONIC KIDNEY DISEASE; DIFFERENTIAL DIAGNOSIS; DISEASE CLASSIFICATION; DRUG INDUCED NEPHROTOXICITY; DRUG OVERDOSE; DRUG RESEARCH; ELDERLY CARE; FOLLOW UP; HUMAN; HYPERKALEMIA; INTERSTITIAL NEPHRITIS; KIDNEY DISEASE; LOW DRUG DOSE; NEPHROTOXICITY; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT; RISK FACTOR; SAFETY; UVEITIS;

ACUTE KIDNEY INJURY; CHRONIC DISEASE; DRUG DISCOVERY; HUMANS; KIDNEY DISEASES; RISK FACTORS; RISK MANAGEMENT;

EID: 84862874952     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.691964     Document Type: Review

References (49)

1. Choudhury D, Ahmed Z. Drug-associated renal dysfunction and injury. Nat Clin Pract Nephrol 2006;2:80-91
2. Lee W, Kim RB. Transporters and renal drug elimination. Annu Rev Pharmacol Toxicol 2004;44:137-66
3. Launay-Vacher V, Izzedine H, Karie S, et al. Renal tubular drug transporters. Nephron Physiol 2006;103:97-106
4. Naughton CA. Drug-induced nephrotoxicity. Am Fam Physician 2008;78:743-50
5. Taber SS, Pasko DA. the epidemiology of drug-induced disorders: The kidney. Expert Opin Drug Saf 2008;7:679-90
6. Uchino S, Kellum JA, Bellomo R, et al. Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: A multinational, multicenter study. JAMA 2005;294:813-18
7. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003;289:1107-16
8. Vaidya VS, Waikar SS, Ferguson MA, et al. Urinary biomarkers for sensitive and specific detection of acute kidney injury in humans. Clin Transl Sci 2008;1:200-8
9. RIFLE Criteria for Acute Renal Dysfunction. Available from: http://www. medicalcriteria.com/criteria/neph-rifle. htm [Last accessed xxxx]
10. Mehta RL, Kellum JA, Shah SV, et al. Acute kidney injury network: Report of an initiative to improve outcomes in acute kidney injury. Crit Care 2007;11:R31
11. Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee. A comparison of the RIFLE and AKIN criteria for acute kidney injury in critically ill patients. Nephrol Dial Transplant 2008;23:1569-74
12. Siew ED, Matheny ME, Ikizler TA, et al. Commonly used surrogates for baseline renal function affect the classification and prognosis of acute kidney injury. Kidney Int 2010;77:536-42
13. Zavada J, Hoste E, Cartin-Ceba R, et al. AKI6 investigators. A comparison of three methods to estimate baseline creatinine for RIFLE classification. Nephrol Dial Transplant 2010;25:3911-18
14. Zappitelli M, Moffett BS, Hyder A, Goldstein SL. Acute kidney injury in non-critically ill children treated with aminoglycoside antibiotics in a tertiary healthcare centre: A retrospective cohort study. Nephrol Dial Transplant 2011;26:144-50
15. Markowitz GS, Perazella MA. Drug-induced renal failure: A focus on tubulointerstitial disease. Clin Chim Acta 2005;351:31-47
16. Mishra J, Dent C, Tarabishi R, et al. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet 2005;365:1231-8
17. Dieterle F, Sistare F, Goodsaid F, et al. Renal biomarker qualification submission: A dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol 2010;28:455-62
18. Charytan D, Kuntz RE. the exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease. Kidney Int 2006;70:2021-30
19. Zhang QL, Rothenbacher D. Prevalence of chronic kidney disease in population-based studies: Systematic review. BMC Public Health 2008;8:117
20. Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States. JAMA 2007;298:2038-47
21. Ponte B, Felipe C, Muriel A, et al. Long-term functional evolution after an acute kidney injury: A 10-year study. Nephrol Dial Transplant 2008;23:3859-66
22. Bates DW, Su L, Yu DT, et al. Mortality and costs of acute renal failure associated with amphotericin B therapy. Clin Infect Dis 2001;32:686-93
23. Tostivint I, du Montcel ST, Jaudon MC, et al. Renal outcome after ciclosporin-induced nephrotoxicity. Nephrol Dial Transplant 2007;22:880-5
24. Schwarz A, Krause P-H, Kunzendorf U, et al. the outcome of acute interstitial nephritis : Risk factors for the transition from acute to chronic interstitial nephritis. Clin Nephrol 2000;54:179-90
25. NKF/KDOQI Definition and classification of stages of chronic kidney disease. Available from: http://www. kidney.org/professionals/kdoqi/guidelines- ckd/p4-class-g1.htm [Last accessed 15 March 2012]
26. Hallan SI, Ritz E, Lydersen S, et al. Combining GFR and albuminuria to classify CKD improves prediction of ESRD. J Am Soc Nephrol 2009;20:1069-77
27. Levey AS, Stevens LA, Schmid CH, et al. CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150:604-12
28. Stevens LA, Schmid CH, Greene T, et al. Comparative Performance of the CKD Epidemiology Collaboration (CKD-EPI) and the Modification of Diet in Renal Disease (MDRD) Study Equations for Estimating GFR Levels Above 60 mL/min/1.73 m2. Am J Kidney Dis 2010;56:486-95
29. John R, Herzenberg AM. Renal toxicity of therapeutic drugs. J Clin Pathol 2009;62:505-15
30. Anglicheau D, Pallet N, Rabant M, et al. Role of P-glycoprotein in cyclosporine cytotoxicity in the cyclosporine-sirolimus interaction. Kidney Int 2006;70:1019-25
31. Zimmermann AE, Pizzoferrato T, Bedford J, et al. Tenofovir-associated acute and chronic kidney disease: A case of multiple drug interactions. Clin Infect Dis 2006;42:283-90
32. Debelle FD, Vanherweghem JL, Nortier JL. Aristolochic acid nephropathy: A worldwide problem. Kidney Int 2008;74:158-69
33. Final Conlusions on the Pilot Joint EMEA/FDA VXDS Experience on the Qualification of Nephrotoxicity Biomarkers. Committee for Medicinal Products for Human Use. Available from: http://www.ema.europa.eu/docs/en-GB/document- library/Regulatory-and-procedural-guideline/2009/10/WC500004205.pdf [Last accessed 12 September 2011]
34. Qualification opinion ILSI/HESI submission of novel renal biomarkers of toxicity. Committee for Medicinal Products for Human Use. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural- guideline/2010/11/WC500099359.pdf [Last accessed 12 September 2011]
35. Leblanc M, Kellum JA, Gibney RT, et al. Risk factors for acute renal failure: Inherent and modifiable risks. Curr Opin Crit Care 2005;11:533-6
36. Perazella MA. Renal vulnerability to drug toxicity. Clin J Am Soc Nephrol 2009;4:1275-83
37. HESI Committee on Biomarkers of Nephrotoxicity. Available from: http://www.hesiglobal.org/i4a/pages/index.cfm? pageID=3541 [Last accessed 12 September 2011]
38. Christensson A, Solve Elmstahl S. Estimation of the age-dependent decline of glomerular filtration rate from formulas based on creatinine and cystatin C in the general elderly population. Nephron Clin Pract 2011;117:c40-50
39. Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff. 2003.Available from: http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm082185.htm [Last accessed 9 March 2012]
40. Bokenkamp A, Domanetzki M, Zinck R, et al. Cystatin C- a new marker of glomerular filtration rate in children independent of age and height. Pediatrics 1998;101:875-81
41. Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling. Available from: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ucm072101.pdf [Last accessed 12 September 2011]
42. Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies in vitro. Available from: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ucm072104.pdf [Last accessed 12 September 2011]
43. Note for Guidance on the Investigation of Drug Interactions. Committee for Proprietary Medicinal Products (CPMP). Available from: http://www.ema. europa. eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002966. pdf [Last accessed 12 September 2011]
44. Kiortsis DN, Filippatos TD, Mikhailidis DP, et al. Statin-associated adverse effects beyond muscle and liver toxicity. Atherosclerosis 2007;195:7-16
45. Verhulst A, D'Haese PC, De Broe ME. Inhibitors of HMG-CoA reductase reduce receptor-mediated endocytosis in human kidney proximal tubular cells. J Am Soc Nephrol 2004;15:2249-57
46. Bonventre JV, vaidya VS, schmarder Ret al. Next-generation biomarkers for detecting kidney toxicity. Nat Biotechnol 2010;28(5):436-40
47. Devarajan P. the use of targeted biomarkers for chronic kidney disease. Adv Chronic Kidney Dis 2010;17(6):469-79; PMID 21044769
48. Available from: http://www.fda.gov/ScienceResearch/ CollaborativeOpportunities/CooperativeResearchandDevelopment AgreementsCRADAs/ucm122820.htm [Last accessed 9 March 2012]
49. Lameire N, Van Biesen W, Vanholder R. Acute renal failure. Lancet 2005;365:417-30