Population pharmacokinetics of darbepoetin alfa in haemodialysis and peritoneal dialysis patients after intravenous administration

British Journal of Clinical Pharmacology

Volumn 63, Issue 3, 2007, Pages 300-309

  Takama, Hirotaka ^a   Tanaka, Hideji ^a   Nakashima, Daisuke ^a   Ogata, Hiroyasu ^b   Uchida, Eiji ^c   Akizawa, Tadao ^d   Koshikawa, Shozo ^e  

^a KIRIN BREWERY CO LTD   (Japan)

^b MEIJI PHARMACEUTICAL UNIVERSITY   (Japan)

^c SHOWA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d WAKAYAMA MEDICAL UNIVERSITY   (Japan)

^e SHOWA UNIVERSITY FUJIGAOKA HOSPITAL   (Japan)

Author keywords

Darbepoetin alfa; Intravenous; NONMEM; Population pharmacokinetics

Indexed keywords

ALANINE AMINOTRANSFERASE; CREATININE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANALYTICAL ERROR; ANEMIA; AREA UNDER THE CURVE; ARTICLE; COMPARTMENT MODEL; CONTROLLED STUDY; COVARIANCE; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG CLEARANCE; FEMALE; HEMODIALYSIS; HEMODIALYSIS PATIENT; HUMAN; INFORMATION PROCESSING; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; PERITONEAL DIALYSIS; PRIORITY JOURNAL; SAMPLE SIZE;

ADULT; AGED; ERYTHROPOIETIN; FEMALE; HEMATINICS; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PERITONEAL DIALYSIS; RENAL DIALYSIS;

EID: 33846958424     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02756.x     Document Type: Article

References (22)

1. Wineals CG, Oliver DO, Pippard MJ, Reid C, Downing MR, Cotes PM. Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet 1986; 2: 1175-8.
2. Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW. Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med 1987; 316: 73-8.
3. Elliott S, Lorenzini T, Asher S, Aoki K, Brankow D, Buck L, Busse L, Chang D, Fuller J, Grant J, Hernday N, Hokum M, Hu S, Kundten A, Levin N, Komorowski R, Martin F, Navarro R, Osslund T, Rogers G, Rogers N, Trail G, Egrie J. Enhancement of therapeutic protein in vivo activities through glycoengineering. Nat Biotechnol 2003; 21: 414-21.
4. Elliott S, Egrie J, Browne J, Lorenzini T, Busse L, Rogers N, Ponting I. Control of rHuEPO biological activity. The role of carbohydrate. Exp Hematol 2004; 32: 1146-55.
5. Egrie JC, Dwyer E, Browne JK, Hitz A, Lykos MA. Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp Hematol 2003; 31: 290-9.
6. Macdougall IC, Gray SJ, Elston O, Breen C, Jenkins B, Egrie J. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 1999; 10: 2392-5.
7. Allon M, Kleinman K, Walczyk M, Kaupke C, Messer-Mann L, Olson K, Heatherington AC, Maroni BJ. Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis. Clin Pharmacol Ther 2002; 72: 546-55.
8. Lerner G, Kale AS, Warady BA, Jabs K, Bunchman TE, Heatherington A, Olsson K, Messer-Mann L, Maroni BJ. Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease. Pediatr Nephrol 2002; 17: 933-7.
9. Hayashi N, Kinoshita H, Yukawa E, Higuchi S. Pharmacokinetic analysis of subcutaneous erythropoietin administration with nonlinear mixed effect model including endogenous production. Br J Clin Pharmacol 1998; 46: 11-19.
10. Chakraborty A, Natarajan J, Guilfoyle M, Morgan N, Vercammen E, Cheung W. Population pharmacokinetics of erythropoietin in critically ill subjects. J Clin Pharmacol 2005; 45: 193-202.
11. Ette EI. Stability and performance of a population pharmacokinetic model. J Clin Pharmacol 1997; 37: 486-95.
12. Roecker EB. Prediction error and its estimation for subset-selected models. Technometrics 1991; 33: 459-68.
13. Efron B. Estimating the error rate of a prediction rule: improvement on cross-validation. J Am Stat Assoc 1983; 78: 316-31.
14. Schoemaker RC, Cohen AF. Estimating impossible curves using NONMEM. Br J Clin Pharmacol 1996; 42: 283-90.
15. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993; 21: 735-50.
16. Takama H, Tanaka H, Sudo T, Tamura T, Tanigawara Y. Population pharmacokinetic modeling and model validation of a spicamycin derivative, KRN5500, in phase 1 study. Cancer Chemother Pharmacol 2001; 47: 404-10.
17. Jonsson EN, Karlsson MO. Xpose - an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Meth Programs Biomed 1999; 58: 51-64.
18. Hastie TJ. Generalized additive models. In: Statistical Models in S, eds Chambers JM, Hastie TJ. Pacific Grove, CA: Wadsworth and Books/Cole Advanced Books & Software 1992: 249-307.
19. Ishibashi T, Yano Y, Oguma T. Population pharmacokinetics of platinum after nedaplatin administration and model validation in adult patients. Br J Clin Pharmacol 2003; 56: 205-13.
20. Jelkmann W. The enigma of the metabolic fate of circulating erythropoietin (Epo) in view of the pharmacokinetics of the recombinant drugs rhEpo and NESP. Eur J Haematol 2002; 69: 265-74.
21. Macdougall IC, Roberts DE, Coles GA, Williams JD. Clinical pharmacokinetics of epoetin (recombinant human erythropoietin). Clin Pharmacokinet 1991; 20: 99-113.
22. Plum J, Schoenicke G, Kleophas W, Kulas W, Steffens F, Azem A, Grabensee B. Comparison of body fluid distribution between chronic heamodialysis and peritoneal dialysis patients as assessed by biophysical and biochemical methods. Nephrol Dial Transplant 2001; 16: 2378-85.