A Population Pharmacokinetic and Pharmacodynamic Analysis of Peginesatide in Patients with Chronic Kidney Disease on Dialysis

PLoS ONE

Volumn 8, Issue 6, 2013, Pages

  Naik, Himanshu ^a   Tsai, Max C ^a   Fiedler Kelly, Jill ^b   Qiu, Ping ^a   Vakilynejad, Majid ^a  

^a TAKEDA PHARMACEUTICALS   (United States)

^b Albany Medical College   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN; PEGINESATIDE; PEPTIDE;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CELL PROLIFERATION; CHRONIC KIDNEY DISEASE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFECT; DRUG ELIMINATION; DRUG EXPOSURE; DRUG RESPONSE; ERYTHROCYTE LIFESPAN; FEMALE; HEMODIALYSIS; HEMOGLOBIN DETERMINATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; OUTCOME ASSESSMENT; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); STEM CELL; BLOOD; DOSE RESPONSE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; RENAL INSUFFICIENCY, CHRONIC; SUBCUTANEOUS DRUG ADMINISTRATION; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ADMINISTRATION, INTRAVENOUS; ADULT; AGED; AGED, 80 AND OVER; ANEMIA; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; PEPTIDES; RENAL DIALYSIS; RENAL INSUFFICIENCY, CHRONIC; UNITED STATES; YOUNG ADULT;

EID: 84879239592     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0066422     Document Type: Article

References (19)

1. National Kidney and Urologic Diseases Information Clearinghouse (2011). Kidney and Urologic Diseases Statistics for the United States. U.S. Department of Health and Human Services. National Institutes of Health. Available: http://www.kidney.niddk.nih.gov. Accessed 19 February 2012.
2. Centers for Disease Control and Prevention (CDC). National chronic kidney disease fact sheet: general information and national estimates on chronic kidney disease in the United States, 2010. Atlanta, GA: U.S. Department of Health and Human Services (HHS), CDC, 2010.
3. US Renal Data System 2011 Annual Data Report. Volume 2. Atlas of End State Renal Disease. United States Renal Data System website. Available: http://www.usrds.org/pdf/v2_00_intro11.pdf. Accessed 19 February 2012.
4. Woodburn KW, Holmes CP, Wilson SD, Fong K-L, Press RJ, et al. (2012) Absorption, distribution, metabolism and excretion of peginesatide, a novel erythropoiesis-stimulating agent, in rats. Xenobiotica 42(7): 660-667.
5. Peginesatide (OMONTYS®) Prescribing Information. Takeda Pharmaceuticals America, Inc. Deerfield, Il 60015. March 2012.
6. Doshi S, Chow A. (2010) Exposure-response modeling of darbepoetin alfa in anemic patients with chronic kidney disease not receiving dialysis. J Clin Pharmacol 50(9 Suppl): 75S-90S.
7. Besarab A, Zeig SN, Martin ER, Pergola PE, Whittier FC, et al. (2012) An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients. BMC Nephrology 13;95 (doi:-10.1186/1471-2369-13-95).
8. Macdougall IC, Wiecek A, Tucker B, Yaqoob M, Mikhail A, et al. (2011) Dose-finding study of peginesatide for anemia correction in chronic kidney disease patients. Clin J Am Soc Nephrol 6: 2579-2586.
9. Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, et al. (2013) Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med 368: 307-319.
10. PDx-Pop: Tools for expediting population analysis. (2009) Version 3.2 User Manual. Ellicot City, MD, ICON Development Solutions.
11. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO, (2011) Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 13(2): 143-151.
12. Roskos LK, Lum P, Lockbaum P, Schwab G, Yang BB, (2006) Pharmacokinetic/pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol 46(7): 747-757.
13. Mircera (methoxy polyethylene glycol-epoetin beta). Summary of product characteristics. F. Hoffmann-La Roche Ltd. Data on File. 2007. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf. Accessed August 10, 2012.
14. Olsson-Gisleskog P, Jacqmin P, (2007) Population pharmacokinetics meta-analysis of recombinant human erythropoietin in healthy subjects. Clin Pharmacokinet 46(2): 159-173.
15. Chanu P, Gieschke R, Charoin JE, Pannier A, Reigner B, (2010) Population pharmacokinetic/pharmacodynamics model for C. E. R. A. in both ESA-naïve and ESA-treated chronic kidney disease patients with renal anemia. J Clin Pharmacol 50(5): 507-520.
16. Boxenbaum H, (1998) Pharmacokinetic tricks and traps: flip-flop models. J Pharm Pharmaceut Sci 1: 90-91.
17. Uehlinger DE, Gotch FA, (1992) A pharmacodynamics model of erythropoietin therapy for uremic anemia. Clin Pharmaco Ther 51(1): 76-89.
18. Woo S, Krzyzanski W, Duliege A-M, Richard SR, Jusko WJ, (2008) Population pharmacokinetic and pharmacodynamic modeling of a novel peptidic erythropoiesis receptor agonist (ERA), in healthy volunteers. J Clin Pharmacol 48: 43-52.
19. Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, et al. (2004) Revised European best practice guidelines for the management of anemia in patients with chronic renal failure. Nephrol Dial Transplant 19(Suppl 2): 1-47.