Kidney function assessment and its role in drug development, review and utilization

References

• Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States. JAMA 2007;298(17):2038-47
   PubMed Web of Science ®Google Scholar
• Weiner DE. Public health consequences of chronic kidney disease. Clin Pharmacol Ther 2009;86(5):566-9
   PubMed Web of Science ®Google Scholar
• US Renal Data System. USRDS 2010 Annual Data Report: atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010. Available from: www.usrds.org/reference.aspx [Last accessed 22 December 2013]
   Google Scholar
• KDIGO. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl 2013;3(1):1-150
   Web of Science ®Google Scholar
• Naud J, Nolin TD, Leblond FA, Pichette V. Current understanding of drug disposition in kidney disease. J Clin Pharmacol 2012;52(1 Suppl):10S-22S
   PubMed Web of Science ®Google Scholar
• Yeung CK, Shen DD, Thummel KE, Himmelfarb J. Effects of chronic kidney disease and uremia on hepatic drug metabolism and transport. Kidney Int 2014;85(3):522-8
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. 1998 Guidance for Industry: pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and Labeling. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072127.pdf [Last accessed 22 December 2013]
   Google Scholar
• European Medicines Agency. 2004 Note for Guidance on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Renal Function. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003123.pdf [Last accessed 22 December 2013]
   Google Scholar
• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16(1):31-41
   PubMed Web of Science ®Google Scholar
• Stevens LA, Coresh J, Greene T, Levey AS. Assessing kidney function--measured and estimated glomerular filtration rate. N Engl J Med 2006;354(23):2473-83
   PubMed Web of Science ®Google Scholar
• Steffl JL, Bennett W, Olyaei AJ. The old and new methods of assessing kidney function. J Clin Pharmacol 2012;52(1 Suppl):63S-71S
   Google Scholar
• Huang SM, Temple R, Xiao S, et al. When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective. Clin Pharmacol Ther 2009;86(5):475-9
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. 2010 Guidance for Industry: pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and Labeling, Revision 1. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204959.pdf [Last accessed 22 December 2013]
   Google Scholar
• European Medicines Agency. 2014 Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162133.pdf [Last accessed 10 March 2014]
   Google Scholar
• Zhang Y, Zhang L, Abraham S, et al. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther 2009;85(3):305-11
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Drugs@FDA Drug Approval Reports. Available from: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu [Last accessed 22 December 2013]
   Google Scholar
• Tortorici MA, Cutler D, Zhang L, Pfister M. Design, conduct, analysis, and interpretation of clinical studies in patients with impaired kidney function. J Clin Pharmacol 2012;52(1 Suppl):109S-18S
   PubMed Web of Science ®Google Scholar
• Schwartz GJ, Haycock GB, Edelmann CM Jr, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58(2):259-63
   PubMed Web of Science ®Google Scholar
• Schwartz GJ, Munoz A, Schneider MF, et al. New equations to estimate GFR in children with. CKD, J Am Soc Nephrol 2009;20(3):629-37
   PubMed Web of Science ®Google Scholar
• Chehade H, Girardin E, Iglesias K, et al. Assessment of adult formulas for glomerular filtration rate estimation in children. Pediatr Nephrol 2013;28(1):105-14
   PubMed Web of Science ®Google Scholar
• Stevens LA, Manzi J, Levey AS, et al. Impact of creatinine calibration on performance of GFR estimating equations in a pooled individual patient database. Am J Kidney Dis 2007;50(1):21-35
   PubMed Web of Science ®Google Scholar
• Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999;130(6):461-70
   PubMed Web of Science ®Google Scholar
• Levey AS, Coresh J, Greene T, et al. Expressing the Modification of Diet in Renal Disease Study equation for estimating glomerular filtration rate with standardized serum creatinine values. Clin Chem 2007;53(4):766-72
   PubMed Web of Science ®Google Scholar
• Stevens LA, Levey AS. Measured GFR as a confirmatory test for estimated. GFR. J Am Soc Nephrol 2009;20(11):2305-13
   PubMed Web of Science ®Google Scholar
• Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150(9):604-12
   PubMed Web of Science ®Google Scholar
• 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(3):486-95
   PubMed Web of Science ®Google Scholar
• Nyman HA, Dowling TC, Hudson JQ, et al. Comparative evaluation of the Cockcroft-Gault Equation and the Modification of Diet in Renal Disease (MDRD) study equation for drug dosing: an opinion of the Nephrology Practice and Research Network of the American College of Clinical Pharmacy. Pharmacotherapy 2011;31(11):1130-44
   PubMed Web of Science ®Google Scholar
• Lamb EJ, Webb MC, Simpson DE, et al. Estimation of glomerular filtration rate in older patients with chronic renal insufficiency: is the modification of diet in renal disease formula an improvement? J Am Geriatr Soc 2003;51(7):1012-17
   PubMed Web of Science ®Google Scholar
• Froissart M, Rossert J, Jacquot C, et al. Predictive performance of the modification of diet in renal disease and Cockcroft-Gault equations for estimating renal function. J Am Soc Nephrol 2005;16(3):763-73
   PubMed Web of Science ®Google Scholar
• de Lemos ML, Hsieh T, Hamata L, et al. Evaluation of predictive formulae for glomerular filtration rate for carboplatin dosing in gynecological malignancies. Gynecol Oncol 2006;103(3):1063-9
   PubMed Web of Science ®Google Scholar
• Wargo KA, Eiland EH 3rd, Hamm W, et al. Comparison of the modification of diet in renal disease and Cockcroft-Gault equations for antimicrobial dosage adjustments. Ann Pharmacother 2006;40(7-8):1248-53
   PubMed Web of Science ®Google Scholar
• Gouin-Thibault I, Pautas E, Mahe I, et al. Is Modification of Diet in Renal Disease formula similar to Cockcroft-Gault formula to assess renal function in elderly hospitalized patients treated with low-molecular-weight heparin? J Gerontol A Biol Sci Med Sci 2007;62(11):1300-5
   PubMed Web of Science ®Google Scholar
• Golik MV, Lawrence KR. Comparison of dosing recommendations for antimicrobial drugs based on two methods for assessing kidney function: cockcroft-gault and modification of diet in renal disease. Pharmacotherapy 2008;28(9):1125-32
   PubMed Web of Science ®Google Scholar
• Melloni C, Peterson ED, Chen AY, et al. Cockcroft-Gault versus modification of diet in renal disease: importance of glomerular filtration rate formula for classification of chronic kidney disease in patients with non-ST-segment elevation acute coronary syndromes. J Am Coll Cardiol 2008;51(10):991-6
   PubMed Web of Science ®Google Scholar
• Hermsen ED, Maiefski M, Florescu MC, et al. Comparison of the Modification of Diet in Renal Disease and Cockcroft-Gault equations for dosing antimicrobials. Pharmacotherapy 2009;29(6):649-55
   PubMed Web of Science ®Google Scholar
• Moranville MP, Jennings HR. Implications of using modification of diet in renal disease versus Cockcroft-Gault equations for renal dosing adjustments. Am J Health Syst Pharm 2009;66(2):154-61
   PubMed Web of Science ®Google Scholar
• Stevens LA, Nolin TD, Richardson MM, et al. Comparison of drug dosing recommendations based on measured GFR and kidney function estimating equations. Am J Kidney Dis 2009;54(1):33-42
   PubMed Web of Science ®Google Scholar
• Jennings S, de Lemos ML, Levin A, Murray N. Evaluation of creatinine-based formulas in dosing adjustment of cancer drugs other than carboplatin. J Oncol Pharm Pract 2010;16(2):113-19
   PubMedGoogle Scholar
• Michels WM, Grootendorst DC, Verduijn M, et al. Performance of the Cockcroft-Gault, MDRD, and new CKD-EPI formulas in relation to GFR, age, and body size. Clin J Am Soc Nephrol 2010;5(6):1003-9
   PubMed Web of Science ®Google Scholar
• Wargo KA, English TM. Evaluation of the chronic kidney disease epidemiology collaboration equation for dosing antimicrobials. Ann Pharmacother 2010;44(3):439-46
   PubMed Web of Science ®Google Scholar
• Hanlon JT, Wang X, Handler SM, et al. Potentially inappropriate prescribing of primarily renally cleared medications for older veterans affairs nursing home patients. J Am Med Dir Assoc 2011;12(5):377-83
   PubMed Web of Science ®Google Scholar
• Jones GR. Estimating renal function for drug dosing decisions. Clin Biochem Rev 2011;32(2):81-8
   PubMedGoogle Scholar
• Healy MF, Speroni KG, Eugenio KR, Murphy PM. Adjusting eptifibatide doses for renal impairment: a model of dosing agreement among various methods of estimating creatinine clearance. Ann Pharmacother 2012;46(4):477-83
   PubMed Web of Science ®Google Scholar
• Park EJ, Wu K, Mi Z, et al. A systematic comparison of cockcroft-gault and modification of diet in renal disease equations for classification of kidney dysfunction and dosage adjustment. Ann Pharmacother 2012;46(9):1174-87
   PubMed Web of Science ®Google Scholar
• Tsao CK, Moshier E, Seng SM, et al. Impact of the CKD-EPI equation for estimating renal function on eligibility for cisplatin-based chemotherapy in patients with urothelial cancer. Clin Genitourin Cancer 2012;10(1):15-20
   PubMed Web of Science ®Google Scholar
• Chin PK, Florkowski CM, Begg EJ. The performances of the cockcroft-gault, modification of diet in renal disease study and chronic kidney disease epidemiology collaboration equations in predicting gentamicin clearance. Ann Clin Biochem 2013;50(Pt 6):546-57
   PubMed Web of Science ®Google Scholar
• Maccallum PK, Mathur R, Hull SA, et al. Patient safety and estimation of renal function in patients prescribed new oral anticoagulants for stroke prevention in atrial fibrillation: a cross-sectional study. BMJ Open 2013;3(9):e003343
   Web of Science ®Google Scholar
• de Lemos ML, Badry N, Hamata L. Limited role of cockcroft-gault formula in dosing information on product labels for antineoplastic drugs. Can J Hosp Pharm 2013;66(4):256
   PubMedGoogle Scholar
• Gill J, Malyuk R, Djurdjev O, Levin A. Use of GFR equations to adjust drug doses in an elderly multi-ethnic group--a cautionary tale. Nephrol Dial Transplant 2007;22(10):2894-9
   PubMed Web of Science ®Google Scholar
• Stevens LA, Levey AS. Use of the MDRD study equation to estimate kidney function for drug dosing. Clin Pharmacol Ther 2009;86(5):465-7
   PubMed Web of Science ®Google Scholar
• Spruill WJ, Wade WE, Cobb HH 3rd. Continuing the use of the Cockcroft-Gault equation for drug dosing in patients with impaired renal function. Clin Pharmacol Ther 2009;86(5):468-70
   PubMed Web of Science ®Google Scholar
• Richardson MM. Precision versus approximation: the trade off in assessing kidney function and drug dosing. Pharmacotherapy 2010;30(8):758-61
   PubMed Web of Science ®Google Scholar
• Matzke GR, Aronoff GR, Atkinson AJ Jr, et al. Drug dosing consideration in patients with acute and chronic kidney disease-a clinical update from Kidney Disease: improving Global Outcomes (KDIGO). Kidney Int 2011;80(11):1122-37
   PubMed Web of Science ®Google Scholar
• Lalonde RL, Kowalski KG, Hutmacher MM, et al. Model-based drug development. Clin Pharmacol Ther 2007;82(1):21-32
   PubMed Web of Science ®Google Scholar
• Lalonde RL, Wagner JA. Drug development perspective on pharmacokinetic studies of new drugs in patients with renal impairment. Clin Pharmacol Ther 2009;86(5):557-61
   PubMed Web of Science ®Google Scholar
• Milligan PA, Brown MJ, Marchant B, et al. Model-based drug development: a rational approach to efficiently accelerate drug development. Clin Pharmacol Ther 2013;93(6):502-14
   PubMed Web of Science ®Google Scholar
• Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 2005;7(3):E503-12
   PubMed Web of Science ®Google Scholar
• Zhang L, Boulton DW, Pfister M. A pharmacometric approach to quantify the impact of chronic kidney disease and hemodialysis on systemic drug exposure: application to saxagliptin. J Clin Pharmacol 2012;52(1 Suppl):126S-33S
   PubMed Web of Science ®Google Scholar
• Leil TA, Feng Y, Zhang L, et al. Quantification of apixaban’s therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose. Clin Pharmacol Ther 2010;88(3):375-82
   PubMed Web of Science ®Google Scholar
• Shlipak MG, Matsushita K, Arnlov J, et al. Cystatin C versus creatinine in determining risk based on kidney function. N Engl J Med 2013;369(10):932-43
   PubMed Web of Science ®Google Scholar