Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfa

Clinical Journal of the American Society of Nephrology

Volumn 8, Issue 4, 2013, Pages 538-545

  Fishbane, Steven ^a   Roger, Simon D ^b   Martin, Edouard ^c   Runyan, Grant ^d   O'Neil, Janet ^d   Qiu, Ping ^d   Locatelli, Francesco ^e  

^a DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

^b GOSFORD HOSPITAL   (Australia)

^c South Florida Nephrology Associates   (United States)

^d TAKEDA PHARMACEUTICALS   (United States)

^e A MANZONI HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PEGINESATIDE;

AGED; ANEMIA; APPETITE; ARTICLE; BILIRUBIN BLOOD LEVEL; BRAIN INFARCTION; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONSTIPATION; COUGHING; DIARRHEA; DIZZINESS; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG SAFETY; FERRITIN BLOOD LEVEL; HEADACHE; HEMODIALYSIS; HEMODIALYSIS PATIENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERKALEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NONCARDIAC CHEST PAIN; OPEN STUDY; PERIPHERAL EDEMA; SIDE EFFECT; THROMBOSIS; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

AGED; AGED, 80 AND OVER; ANEMIA; DOSE-RESPONSE RELATIONSHIP, DRUG; ERYTHROPOIETIN; FEMALE; HEMATINICS; HEMOGLOBINS; HUMANS; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; PEPTIDES; RENAL DIALYSIS; TREATMENT OUTCOME;

EID: 84876014895     PISSN: 15559041     EISSN: 1555905X     Source Type: Journal    
DOI: 10.2215/CJN.03440412     Document Type: Article

References (26)

1. Zoccali C, Kramer A, Jager KJ: Chronic kidney disease and endstage renal disease - a reviewproduced to contribute to the report 'the status of health in the European Union: Towards a healthier Europe'. NDT Plus 3: 213-224, 2010
2. Mercadal L, Metzger M, Casadevall N, Haymann JP, Karras A, Boffa JJ, Flamant M, Vrtovsnik F, Stengel B, Froissart M; NephroTest Study Group: Timing and determinants of erythropoietin deficiency in chronic kidney disease. Clin J Am Soc Nephrol 7: 35-42, 2012
3. Kausz AT, Levey AS: The care of patients with chronic kidney disease. J Gen Intern Med 17: 658-662, 2002
4. Locatelli F, Pisoni RL, Combe C, Bommer J, Andreucci VE, Piera L, Greenwood R, Feldman HI, Port FK, Held PJ: Anaemia in haemodialysis patients of five European countries: Association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 19: 121-132, 2004
5. Holland DC, Lam M: Predictors of hospitalization and death among pre-dialysis patients: A retrospective cohort study. Nephrol Dial Transplant 15: 650-658, 2000
6. Kosiborod M, Smith GL, Radford MJ, Foody JM, Krumholz HM: The prognostic importance of anemia in patients with heart failure. Am J Med 114: 112-119, 2003
7. Evans RW, Rader B, Manninen DL; Cooperative Multicenter EPO Clinical Trial Group: The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. JAMA 263: 825-830, 1990
8. Gerson A, Hwang W, Fiorenza J, Barth K, Kaskel F, Weiss L, Zelikovsky N, Fivush B, Furth S: Anemia and health-related quality of life in adolescents with chronic kidney disease. Am J Kidney Dis 44: 1017-1023, 2004
9. Revicki DA, Brown RE, Feeny DH, Henry D, Teehan BP, Rudnick MR, Benz RL: Health-related quality of life associated with recombinant human rythropoietin therapy for predialysis chronic renal disease patients. Am J Kidney Dis 25: 548-554, 1995
10. Ross SD, Fahrbach K, Frame D, Scheye R, Connelly JE, Glaspy J: The effect of anemia treatment on selected health-related quality-of-life domains: A systematic review. Clin Ther 25: 1786-1805, 2003
11. Eschbach JW, Abdulhadi MH, Browne JK, Delano BG, Downing MR, Egrie JC, Evans RW, Friedman EA, Graber SE, Haley NR, Korbet S, Krantz SB, Lundin AP, Nissenson AR, Ogden DA, Paganini EP, Rader B, Rutsky EA, Stivelman J, Stone WJ, Teschan P, Von Stone JC, Van Wyck DB, Zuckerman K, Adamson JW: Recombinant human erythropoietin in anemic patients with endstage renal disease. Results of a phase III multicenter clinical trial. Ann Intern Med 111: 992-1000, 1989
12. Maddux FW, Shetty S, del Aguila MA, Nelson MA, Murray BM: Effect of erythropoiesis-stimulating agents on healthcare utilization, costs, and outcomes in chronic kidney disease. Ann Pharmacother 41: 1761-1769, 2007
13. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, Schwab SJ, Goodkin DA: The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 339: 584-590, 1998
14. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators: Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 355: 2085-2098, 2006
15. Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R; TREAT Investigators: A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 361: 2019-2032, 2009
16. Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU: A peptide-based erythropoietinreceptor agonist for pure red-cell aplasia. N Engl J Med 361: 1848-1855, 2009
17. Epogen (epoetin alfa) for Injection [prescribing information]. Thousand Oaks, CA, Amgen Inc, 2010
18. Schiller B, Doss S, DE Cock E, Del Aguila MA, Nissenson AR: Costs ofmanaging anemia with erythropoiesis-stimulating agents during hemodialysis: A time and motion study. Hemodial Int 12: 441-449, 2008
19. Aranesp (darbepoetin alfa) for Injection [prescribing information], Thousand Oaks, CA, Amgen Inc, 2010
20. MIRCERA Product Information: Annex 1: Summary of product characteristics. Available at: http://www.emea.europa.eu/humandocs/Humans/EPAR/mircera/mircera.htm. Accessed July 23, 2011
21. Fan Q, Leuther KK, Holmes CP, Fong KL, Zhang J, Velkovska S, Chen MJ, Mortensen RB, Leu K, Green JM, Schatz PJ, Woodburn KW: Preclinical evaluation of Hematide, a novel erythropoiesis stimulating agent, for the treatment of anemia. Exp Hematol 34: 1303-1311, 2006
22. Besarab A, Locatelli F, Covic A, Martin E, Bernardo M, Macdougall I, Tang H, Mayo M, Polu K, Duliege AM: Safety and efficacy of peginesatide for treatment of anemia in hemodialysis patients previously on epoetin alfa or beta [Abstract]. Am J Kidney Dis 57: A25, 2011
23. Schiller B, Zeig S, Hura C, Levin N, Kaplan M, Tang H, Mayo M, Polu K, Duliegge AM: Safety and efficacy of peginesatide for treatment of anemia in hemodialysis patients previously on epoetin alfa [Abstract]. Am J Kidney Dis 57: A85, 2011
24. National Cancer Institute: Cancer Therapy Evaluation Program, Common terminology criteria for adverse events, version 3.0. Available at: http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf. Published August 9, 2006. Accessed June 11, 2011
25. Curran MP, McCormack PL: Methoxy polyethylene glycolepoetin beta: A review of its use in the management of anaemia associated with chronic kidney disease. Drugs 68: 1139-1156, 2008
26. Robinson DM, Easthope SE: Darbepoetin alfa: Its use in anemia associated with chronic kidney disease. BioDrugs 19: 327-343, 2005