Design of informative renal impairment studies: Evaluation of the impact of design stratification on bias, precision and dose adjustment error

Investigational New Drugs

Volumn 32, Issue 5, 2014, Pages 913-927

  Van Hasselt, J G Coen ^a,c   Schellens, Jan H M ^a,b   Beijnen, Jos H ^a,b   Huitema, Alwin D R ^a  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c LEIDEN UNIVERSITY   (Netherlands)

Author keywords

Modelling; Pharmacokinetics; Renal impairment; Simulation; Study design

Indexed keywords

BIOLOGICAL MODEL; DOSE RESPONSE; HUMAN; KIDNEY FAILURE; METABOLISM; METHODOLOGY; PHARMACOKINETICS;

DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; RENAL INSUFFICIENCY; RESEARCH DESIGN;

EID: 84930725336     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-014-0103-8     Document Type: Article

References (35)

1. U.S. 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. Analysis. http://www.fda.gov/downloads/Drugs/Guidances/UCM204959.pdf.
2. Ibrahim S, Honig P, Huang SM et al (2000) Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives. J Clin Pharmacol 40:31-38
3. Zhang Y, Zhang L, Abraham S et al (2009) Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther 85:305-311
4. Committee for medicinal products for human use, European Medicines Agency (2004) Note for guidance on the evaluation of the pharmacokinetics ofmedicinal products in patients with impaired renal function. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003123.pdf.
5. Kubitza D, Becka M, Mueck Wet al (2010) Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol 70:703-712
6. Lobo ED, Heathman M, Kuan H-Y et al (2010) Effects of varying degrees of renal impairment on the pharmacokinetics of duloxetine: analysis of a single-dose phase I study and pooled steady-state data from phase II/III trials. Clin Pharmacokinet 49:311-321
7. Rahman A, White RM (2006) Cytotoxic anticancer agents and renal impairment study: the challenge remains. J Clin Oncol 24:533-536
8. Clinicaltrials.gov.
9. Green B, Greenwood M, Saltissi D et al (2005) Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes. Br J Clin Pharmacol 59:281-290
10. Beal SL, Sheiner LB, Boeckman AJ, Bauer RJ (2009) NONMEM user's guides (1989-2009). Icon Development Solutions, Ellicott City
11. Lindbom L, Ribbing J, Johnsson E (2004) Perl-speaks-NONMEM (PsN) - A Perl module for NONMEMrelated programming. Comput Method Prog Biomed 75:85-94
12. R Development Core Team (2011) R: A language and environment for statistical computing. Vienna, Austria
13. Devriese LA (2011) Pharmacokinetics of novel anticancer drugs and dynamics of circulating tumor cells in early clinical studies. Utrecht University, Netherlands, p 45-66. http://dspace.library.uu.nl/handle/1874/212943
14. Lal R, Sukbuntherng J, Luo W et al (2012) Clinical pharmacokinetics of gabapentin after administration of gabapentin enacarbil extended-release tablets in patients with varying degrees of renal function using data from an open-label, single-dose pharmacokinetic study. Clin Ther 34:201-213
15. Li Z, Tenhoor C, Marbury T et al (2011) Pharmacokinetics and pharmacodynamics of tonapofylline in subjects with severe renal impairment and in elderly subjects. Int J Clin Pharmacol Ther 49:563-570
16. Galsky MD, Camacho LH, Chiorean EG et al (2012) Phase I study of the effects of renal impairment on the pharmacokinetics and safety of satraplatin in patients with refractory solid tumors. Ann Oncol 23:1037-1044
17. Bethke TD, Hartmann M, Hünnemeyer A et al (2011) Influence of renal impairment on the pharmacokinetics of oral roflumilast: an open-label, parallel-group, single-center study. Int J Clin Pharmacol Ther 49:491-499
18. Cawello W, Ahrweiler S, Sulowicz W et al (2012) Single dose pharmacokinetics of the transdermal rotigotine patch in patients with impaired renal function. Br J Clin Pharmacol 73:46-54
19. Graefe-Mody U, Friedrich C, Port A et al (2011) Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin(∗). Diabetes Obes Metab 13:939-946
20. Peeters P, Bockbrader H, Spaans E et al (2011) Asenapine pharmacokinetics in hepatic and renal impairment. Clin Pharmacokinet 50:471-481
21. Gschwend S, Ebert W, Schultze-Mosgau M, Breuer J (2011) Pharmacokinetics and imaging properties of Gd-EOB-DTPA in patients with hepatic and renal impairment. Invest Radiol 46:556-566
22. Kosaka T, Hosokawa K, Shime N et al (2012) Effects of renal function on the pharmacokinetics and pharmacodynamics of prophylactic cefazolin in cardiothoracic surgery. Eur J Clin Microbiol Infect Dis 31:193-199
23. Tomkinson H, Kemp J, Oliver S et al (2011) Pharmacokinetics and tolerability of zibotentan (ZD4054) in subjects with hepatic or renal impairment: two open-label comparative studies. BMC Clin Pharmacol 11:3
24. Schmid K, Pascual S, Gil EG et al (2010) Pharmacokinetics and safety of aclidinium bromide, A muscarinic antagonist, in adults with normal or impaired renal function: a phase I, open-label, single-dose clinical trial. Clin Ther 32:1798-1812
25. Bauman JW, Antal JM, Adams LM et al (2012) Effect of hepatic or renal impairment on the pharmacokinetics of casopitant, a NK-1 receptor antagonist. Invest New Drugs 30:662-671
26. Nichols AI, Richards LS, Behrle JA et al (2011) The pharmacokinetics and safety of desvenlafaxine in subjects with chronic renal impairment. Int J Clin Pharmacol Ther 49:3-13
27. Shiffman ML, Pol S, Rostaing L et al (2011) Efficacy and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and renal impairment. J Clin Pharmacol 51:1293-1301
28. Bruderer S, Sasu B, Tsvitbaum N, Dingemanse J (2011) Influence of severe renal impairment on the pharmacokinetics of clazosentan. J Clin Pharmacol 51:413-421
29. Bauman JW, Vincent CT, Peng B et al (2011) Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. J Clin Pharmacol 51:739-750
30. Stangier J, Rathgen K, Stähle H, Mazur D (2010) Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet 49:259-268
31. Smith JP, Weller S, Johnson B et al (2010) Pharmacokinetics of acyclovir and its metabolites in cerebrospinal fluid and systemic circulation after administration of high-dose valacyclovir in subjects with normal and impaired renal function. Antimicrob Agents Chemother 54:1146-1151
32. Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M (2009) Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol 68:898-905
33. Smith W, Swan S, Marbury T, Henney H (2010) Single-Dose pharmacokinetics of sustained-release fampridine (Fampridine-SR) in healthy volunteers and adults with renal impairment. J Clin Pharmacol 50:151-159
34. Khosravan R, Toh M, Garrett M et al (2010) Pharmacokinetics and safety of sunitinib malate in subjects with impaired renal function. J Clin Pharmacol 50:472-481
35. Small DS, Wrishko RE, Ernest CS et al (2009) Prasugrel pharmacokinetics and pharmacodynamics in subjects with moderate renal impairment and end-stage renal disease. J Clin Pharm Ther 34:585-594