Bibliography
- JONES C, MCQUILLAN G, KUSEK J et al.: Serum creatinine levels in the US population: Third National Health and Nutrition Examination Survey. Am. I Kidney Dis. (1998) 32:992–999.
- 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).
- CARO J, BROWN S, MILLER 0, MURRAY T, ERSLEV AJ: Erythropoietin levels in uremic, nephric and anephric patients. I Lab. Clin. Med. (1979) 93:449–458.
- ESCHBACH JVV: The anemia of chronic renal failure: pathophysiology and the effects of recombinant erythropoietin. Kidney hat. (1989) 35:134–148.
- ESCHBACH JW, DOWNING MR, EGRIE JC et al.: USA multicenter clinical trial with recombinant human erythropoietin. Contrib. Nephrol. (1989) 76:160–165.
- 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.
- JOY MS: Darbepoetin alfa: a novel erythropoiesis-stimulating protein. Ann. Pharmacother. (2002) 36:1183–1192.
- MACDOUGALL IC, GRAY SJ, ELSTON 0 et al: Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. I Am. Soc. Nephrol. (1999) 10:2392–2395.
- ••A core study establishing the longer half-lifeof darbepoetin alfa relative to rHuEPO.
- 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 developmentof darbepoetin alfa and its pharmacology.
- AMGEN INC.: Aranesp° (darbepoetin alfa) package insert. Thousand Oaks, CA (2001).
- NISSENSON AR: Novel erythropoesis stimulating protein for managing the anemia of chronic kidney disease. Am. I Kidney Dis. (2001) 38:1390–1397.
- ••A comprehensive overview of darbepoetinalfa preclinical and clinical trial data.
- MACDOUGALL IC: Novel erythropoiesis stimulating protein. Semin. Nephrol. (2000) 20:375–381.
- 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.
- AKAHORI H, TAWARA T, IDA M, MIYAZAKI H: The effect of novel erythropoiesis stimulating protein (NESP) on anemia induced by renal failure in rats. Exp. Hematol. (1998) 26:766.
- ALLON M, KLEINMAN K, WALCZYK M et al.: The pharmacokinetics of novel erythropoiesis stimulating protein (NESP) following intravenous administration is time-and dose-linear. I 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].
- 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. I Am. Soc. Nephrol.(2000) 11:A1317.
- 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. 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. Title: Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease].
- EVANS JH, BROCKLEBANK JT, BOWMER CJ, NG PC: Pharmacokinetics of recombinant human erythropoietin inchildren with renal failure. Nephrol. Dial. Transplant. (1991) 6:709–714.
- GLASPY J, JADEJA J, JUSTICE Get at.: Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br. Cancer. (2002) 87:268–276.
- 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.
- GLASPY J, JADEJA J, JUSTICE G et a/.: Optimizing the management of anemia in cancer patients: a randomised, active-controlled study investigating the dosing of darbepoetin alfa. Proc. ASCO(2002) 21:367a.
- 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.
- 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 Socie0, of Nephrology/International Socie0, of Nephrology World Congress of Nephrology San Francisco, CA, USA (2001).
- MACDOUGALL IC: Darbepoetin alfa: a new therapeutic agent for renal anemia. Kidney Int. (2002) 61\(Suppl. 80):555–561.
- ••A comprehensive overview of darbepoetinalfa predinical and clinical trial data.
- LOCATELLI F, OLIVARES J, WALKER R: Novel erythropoiesis stimulating protein for treatment of anemia in chronic renal insufficiency. Kidney hat. (2001)60:741–747.
- ••A core study reporting data on the efficacyand tolerability of darbepoetin alfa in patients with CKD not receiving dialysis.
- 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).
- NISSENSON AR, SWAN SK, LINDBERG JS et al.: Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am. I Kidney Dis. (2002) 40:110–118.
- 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.' 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].
- 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 theNational 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.
- 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.
- CASADEVALL N, NATAF J, VIRON B et al.: Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl. Med. (2002) 346:469–475.
- 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.
- http://www.health.gov/healthypeople NATIONAL INSTITUTES OF HEALTH: Healthy people 2010: chronic kidney disease 2000.