Darbepoetin alfa: A new therapy for the management of anaemia associated with chronic kidney disease

Expert Opinion on Biological Therapy

Volumn 2, Issue 8, 2002, Pages 977-984

  Lindberg, Jill ^a  

^a OCHSNER CLINIC FOUNDATION   (United States)

Author keywords

Anaemia; Chronic kidney disease; Darbepoetin alfa

Indexed keywords

CARBOHYDRATE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; SIALIC ACID;

ABDOMINAL PAIN; ANEMIA; ARTHRALGIA; CAREGIVER; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; DIARRHEA; DISEASE ASSOCIATION; DOSE RESPONSE; DRUG ACTIVITY; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; DRUG EFFECT; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG TOLERANCE; DYSPNEA; HEADACHE; HEALTH CARE FACILITY; HEALTH CARE PERSONNEL; HEMATOPOIESIS; HEMOGLOBIN DETERMINATION; HUMAN; HYPERTENSION; HYPOTENSION; INJECTION; LONG TERM CARE; MYALGIA; NAUSEA; NONHUMAN; PERIPHERAL EDEMA; PROTEIN STRUCTURE; QUALITY OF LIFE; REVIEW; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

ANEMIA; ANIMALS; ERYTHROPOIETIN; HUMANS; KIDNEY FAILURE, CHRONIC;

QUERCUS;

EID: 0036914205     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2.8.977     Document Type: Review

References (32)

1. Jones C, McQuillan G, Kusek J et al: Serum creatinine levels in the US population: Third National Health and Nutrition Examination Survey. Am. J. Kidney Dis. (1998) 32:992-999.
2. Lindberg J, Foret J, Pitts L et al: Impact of rHuEPO injections on the daily routines of CRI patients. Proceedings of the 33rd National Symposium of the American Nephrology Nurses' Association Congress. Orlando, FL, USA (2002).
3. Caro J, Brown S, Miller O, Murray T, Erslev AJ: Erythropoietin levels in uremic, nephric and anephric patients. J. Lab. Clin. Med. (1979) 93:449-458.
4. Eschbach JW: The anemia of chronic renal failure: Pathophysiology and the effects of recombinant erythropoietin. Kidney Int. (1989) 35:134-148.
5. Eschbach JW, Downing MR, Egrie JC et al.: USA multicenter clinical trial with recombinant human erythropoietin. Contrib. Nephrol. (1989) 76:160-165.
6. Sundal E, Kaeser U: Correction of anaemia of chronic renal failure with recombinant human erythropoietin: Safety and efficacy of one year's treatment in a European multicentre study of 150 haemodialysis-dependent patients. Nephrol. Dial Transplant. (1989) 4:979-987.
7. Joy MS: Darbepoetin alfa: A novel erythropoiesis-stimulating protein. Ann. Pharmacother. (2002) 36:1183-1192.
8. MacDougall IC, Gray SJ, Elston O et al: Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J. Am. Soc. Nephrol. (1999) 10:2392-2395. A core study establishing the longer half-life of darbepoetin alfa relative to rHuEPO.
9. Egrie JC, Browne JK: Development and characterization of novel erythropoiesis stimulating protein (NESP). Nephrol. Dial. Transplant. (2001) 16(Suppl 3):3-13. Reviews the rationale for the development of darbepoetin alfa and its pharmacology.
10. AMGEN INC.: Aranesp® (darbepoetin alfa) package insert. Thousand Oaks, CA (2001).
11. Nissenson AR: Novel erythropoesis stimulating protein for managing the anemia of chronic kidney disease. Am. J. Kidney Dis. (2001) 38:1390-1397. A comprehensive overview of darbepoetin alfa preclinical and clinical trial data.
12. MacDougall IC: Novel erythropoiesis stimulating protein. Semin. Nephrol. (2000) 20:375-381.
13. Egrie JC, Dwyer E, Lykos M, Hitz A, Browne JK: Novel erythropoiesis stimulating protein (NESP) has a longer serum half-life and greater in vivo biological activity than recombinant human erythropoietin (rHuEPO). Blood (1997) 90:56a.
14. Akahori H, Tawara T, Ida M, Miyazaki H: The effect of novel eryrhropoiesis stimulating protein (NESP) on anemia induced by renal failure in rats. Exp. Hematol. (1998) 26:766.
15. Allon M, Kleinman K, Walczyk M et al: The pharmacokinetics of novel erythropoiesis stimulating protein (NESP) following intravenous administration is time- and dose-linear. J. Am. Soc. Nephrol. (2000) 11:A1308. [Accepted as a full paper in Clinical Pharmacology and Therapeutics, August 2002. Title: Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in dialysis patients].
16. Graf H, Lacombe J-L, Braun J, Gomes DA Costa AA, and The European/Australian NESP 980140/194 STUDY GROUP: Novel erythropoiesis stimulating protein (NESP) effectively maintains hemoglobin (Hb) when administered at a reduced dose frequency compared with recombinant human erythropoietin (r-HuEPO) in ESRD patients. J. Am. Soc. Nephrol. (2000) 11:A1317.
17. Lerner GR, Kale AS, Warady BA et al: The pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in pediatric patients with chronic renal failure (CRF) or end-stage renal disease. J. Am. Soc. Nephrol. (2000) 11:A1479. [Accepted as a full paper by Pediatric Nephrology, September 2002. Available online: DOI 10.1007/ s00467-002-0932-0. Tide: Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease].
18. Evans JH, Brocklebank JT, Bowmer CJ, Ng PC: Pharmacokinetics of recombinant human erythropoietin in children with renal failure. Nephrol. Dial. Transplant. (1991) 6:709-714.
19. Glaspy J, Jadeja J, Justice G et al: Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br. J. Cancer. (2002) 87:268-276.
20. Kotasek D, Albertsson M, Mackey J et al: Randomized, double-blind, placebo-controlled, dose-finding study of darbepoetin alfa administered once every 3 (Q3W) or 4 (Q4W) weeks in patients with solid tumors. Proc. ASCO (2002) 21:356a.
21. Glaspy J, Jadeja J, Justice G et al: Optimizing the management of anemia in cancer patients: A randomised, active-controlled study investigating the dosing of darbepoetin alfa. Proc. ASCO (2002) 21:367a.
22. Smith R, Tchekmedyian S, Richards D et al: Darbepoetin alfa effectively alleviates anemia in patients with chronic anemia of cancer: Efficacy and pharmacokinetic results of a dose-escalation study. Proc. ASCO (2002) 21:367a.
23. Bochicchio T, Correa-Rotter R, Trinidad RP et al: Novel erythropoiesis stimulating protein effectively maintains hemoglobin when administered at a reduced dose frequency compared with recombinant human erythropoietin in dialysis patients in Mexico. Proceedings of the American Society of Nephrology/International Society of Nephrology World Congress of Nephrology. San Francisco, CA, USA (2001).
24. MacDougall IC: Darbepoetin alfa: A new therapeutic agent for renal anemia. Kidney Int. (2002) 61(Suppl. 80):S55-S61. A comprehensive overview of darbepoetin alfa preclinical and clinical trial data.
25. Locatelli F, Olivares J, Walker R: Novel erythropoiesis stimulating protein for treatment of anemia in chronic renal insufficiency. Kidney Int. (2001) 60:741-747. A core study reporting data on the efficacy and tolerability of darbepoetin alfa in patients with CKD not receiving dialysis.
26. Lindberg JS, Navarro J, Suranyi M, Walker R: Aranesp™ (darbepoetin alfa) administered once every other week (q2w) corrects anemia in patients with chronic kidney disease (CKD). Proceedings of the National Kidney Foundation Clinical Nephrology Meeting. Chicago, IL, USA (2002).
27. Nissenson AR, Swan SK, Lindberg JS et al: Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am. J. Kidney Dis. (2002) 40:110-118.
28. Vanrenterghem Y, Barany P, Mann J: Novel erythropoiesis stimulating protein (NESP) maintains Hb in ESRD patients when administered once weekly or once every other week. J. Am. Soc. Nephrol. (1999) 10:270A. [Accepted as a full paper by Kidney International, August 2002. Title: Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with epoetin alfa in dialysis patients].
29. Walker R: Aranesp™ (darbepoetin alfa) administered at a reduced frequency of once every 4 weeks (q4w) maintains hemoglobin levels in patients with chronic kidney disease receiving dialysis. Proceedings of the National Kidney Foundation Clinical Nephrology Meeting. Chicago, IL, USA (2002). An abstract reporting data on the efficacy and tolerability of darbepoetin alfa with once-monthly dosing.
30. Rahman SN, Heifner KJ, Fadem SZ et al: HRQOL improvements in anemic CKD patients treated with darbepoetin alfa (Aranesp™). Proceedings of the National Kidney Foundation Clinical Nephrology Meeting. Chicago, IL, USA (2002). An abstract assessing the impact of early anaemia correction on HRQOL in patients with CKD.
31. Casadevall N, Nataf J, Viron B et al.: Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. (2002) 346:469-475.
32. Janssen-Ortho INC, Ortho Biotech: Important new safety information EPREX (epoetin alfa): Reports of pure red blood cell aplasia. Healthcare Professional Letter (2001) November 26.