메뉴 건너뛰기




Volumn 12, Issue 5, 2007, Pages 431-436

Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis

Author keywords

Anemia; Biogeneric; Biosimilar; Chronic kidney disease; Epoetin; Follow on biologic

Indexed keywords

GENERIC DRUG; GEREPO; HEMOGLOBIN; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

EID: 34548426486     PISSN: 13205358     EISSN: 14401797     Source Type: Journal    
DOI: 10.1111/j.1440-1797.2007.00831.x     Document Type: Article
Times cited : (11)

References (28)
  • 1
    • 0024495259 scopus 로고
    • The anaemia of chronic renal failure: Pathophysiology and the effects of recombinant erythropoietin
    • Eschbach JW. The anaemia of chronic renal failure: Pathophysiology and the effects of recombinant erythropoietin. Kidney Int. 1989 35 : 134 48.
    • (1989) Kidney Int. , vol.35 , pp. 134-48
    • Eschbach, J.W.1
  • 2
    • 0025190665 scopus 로고
    • The quality of life of hemodialysis recipients treated with recombinant human erythropoietin
    • Cooperative Multicenter EPO Clinical Trial Group.
    • 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 1990 263 : 825 30.
    • (1990) JAMA , vol.263 , pp. 825-30
    • Evans, R.W.1    Rader, B.2    Manninen, D.L.3
  • 3
    • 0003071396 scopus 로고
    • The relative contribution of measured variables to death risk among hemodialysis patients
    • In: Friedman, E.A. (ed.). Boston, MA: Kluwer Academic Publishers
    • Lowrie EG, Ling J, Lew NL, Yiu Y. The relative contribution of measured variables to death risk among hemodialysis patients. In : Friedman EA (ed.). Death on Hemodialysis: Preventable or Inevitable? Boston, MA : Kluwer Academic Publishers, 1994 121 41.
    • (1994) Death on Hemodialysis: Preventable or Inevitable? , pp. 121-41
    • Lowrie, E.G.1    Ling, J.2    Lew, N.L.3    Yiu, Y.4
  • 4
    • 4344581912 scopus 로고    scopus 로고
    • Revised European best practice guidelines for the management of anemia in patients with chronic renal failure
    • EBPG II Working Group.
    • EBPG II Working Group. Revised European best practice guidelines for the management of anemia in patients with chronic renal failure. Nephrol. Dial. Transplant. 2004 19 (Suppl 2 ii1 47.
    • (2004) Nephrol. Dial. Transplant. , vol.19 , Issue.SUPPL. 2
  • 5
    • 0035228407 scopus 로고    scopus 로고
    • NKF-K/DOQI clinical practice guidelines for anaemia of chronic kidney disease, update 2000
    • NKF-K/DOQI clinical practice guidelines for anaemia of chronic kidney disease, update 2000. Am. J. Kidney Dis. 2001 37 (Suppl 1 S182 238.
    • (2001) Am. J. Kidney Dis. , vol.37 , Issue.SUPPL. 1
  • 6
    • 34548417368 scopus 로고    scopus 로고
    • United States Renal Data System 2003.Annual Data Report 2003. [Cited 15 Jan 2006.] Available from URL:
    • United States Renal Data System 2003. Annual Data Report 2003. [Cited 15 Jan 2006.] Available from URL: http://www.usrds.org//pdf
  • 7
    • 0026865149 scopus 로고
    • A comparison of the costs and benefits of recombinant human erythropoietin (epoetin) in the treatment of chronic renal failure in 5 European countries
    • Leese B, Hutton J, Maynard A. A comparison of the costs and benefits of recombinant human erythropoietin (epoetin) in the treatment of chronic renal failure in 5 European countries. Pharmacoeconomics 1992 1 : 346 56.
    • (1992) Pharmacoeconomics , vol.1 , pp. 346-56
    • Leese, B.1    Hutton, J.2    Maynard, A.3
  • 8
    • 0032795554 scopus 로고    scopus 로고
    • Trends in use, cost and outcomes of recombinant human erythropoietin 1989-1998
    • Greer JW, Milam RA, Eggers PW. Trends in use, cost and outcomes of recombinant human erythropoietin 1989-1998. Health Care Finance Rev. 1999 20 : 55 62.
    • (1999) Health Care Finance Rev. , vol.20 , pp. 55-62
    • Greer, J.W.1    Milam, R.A.2    Eggers, P.W.3
  • 9
    • 0042708598 scopus 로고    scopus 로고
    • Anemia management prior to dialysis: Cardiovascular and cost-benefit observations
    • Collins AJ. Anemia management prior to dialysis: Cardiovascular and cost-benefit observations. Nephrol. Dial. Transplant. 2003 18 (Suppl 2 ii2 6.
    • (2003) Nephrol. Dial. Transplant. , vol.18 , Issue.SUPPL. 2
    • Collins, A.J.1
  • 12
    • 9144264827 scopus 로고    scopus 로고
    • Anaemia in haemodialysis patients in five European countries: Association with morbidity and mortality in the Dialysis Outcomes and Practice Pattern Study (DOPPS)
    • Locatelli F, Pisoni RL, Combe C et al. Anaemia in haemodialysis patients in five European countries: Association with morbidity and mortality in the Dialysis Outcomes and Practice Pattern Study (DOPPS). Nephrol. Dial. Transplant. 2004 19 : 121 32.
    • (2004) Nephrol. Dial. Transplant. , vol.19 , pp. 121-32
    • Locatelli, F.1    Pisoni, R.L.2    Combe, C.3
  • 13
    • 3042772186 scopus 로고    scopus 로고
    • Anaemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Pattern Study (DOPPS)
    • Pisoni RL, Bragg-Gresham JL, Young EW et al. Anaemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Pattern Study (DOPPS). Am. J. Kidney Dis. 2004 44 : 94 111.
    • (2004) Am. J. Kidney Dis. , vol.44 , pp. 94-111
    • Pisoni, R.L.1    Bragg-Gresham, J.L.2    Young, E.W.3
  • 14
    • 34548393889 scopus 로고    scopus 로고
    • (eds). 12th Report of the National Renal Registry 2004. Kuala Lumpur 2005. [Cited 15 Jan 2006.] Available from URL:
    • Lim YN, Lim TO (eds). 12th Report of the National Renal Registry 2004. Kuala Lumpur 2005. [Cited 15 Jan 2006.] Available from URL: http://www.msn.org. my/nrr/
    • Lim, Y.N.1    Lim, T.O.2
  • 15
    • 19044374719 scopus 로고    scopus 로고
    • Biosimilar epoetins: How similar are they?
    • Schellekens H. Biosimilar epoetins: How similar are they? Eur. J. Hosp. Pharm. 2004 3 : 43 7.
    • (2004) Eur. J. Hosp. Pharm. , vol.3 , pp. 43-7
    • Schellekens, H.1
  • 19
    • 0023120533 scopus 로고
    • Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of combined phase I and II trials
    • Eschbach JW, Egrie JC, Downing MR et al. Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of combined phase I and II trials. N. Engl. J. Med. 1987 316 : 73 8.
    • (1987) N. Engl. J. Med. , vol.316 , pp. 73-8
    • Eschbach, J.W.1    Egrie, J.C.2    Downing, M.R.3
  • 20
    • 0022980521 scopus 로고
    • Effect of human erythropoietin derived from recombinant DNA on the anemia of patients maintained by chronic hemodialysis
    • Winearls CG, Oliver DO, Pippard MJ et al. Effect of human erythropoietin derived from recombinant DNA on the anemia of patients maintained by chronic hemodialysis. Lancet 1986 2 : 1175 7.
    • (1986) Lancet , vol.2 , pp. 1175-7
    • Winearls, C.G.1    Oliver, D.O.2    Pippard, M.J.3
  • 21
    • 0024790160 scopus 로고
    • Recombinant human erythropoietin in anemic patients with end-stage renal disease: Results of a phase III multicenter trial
    • Eschbach JW, Abdulhadi MH, Browne JK et al. Recombinant human erythropoietin in anemic patients with end-stage renal disease: Results of a phase III multicenter trial. Ann. Intern. Med. 1989 111 : 992 1000.
    • (1989) Ann. Intern. Med. , vol.111 , pp. 992-1000
    • Eschbach, J.W.1    Abdulhadi, M.H.2    Browne, J.K.3
  • 22
    • 0032694404 scopus 로고    scopus 로고
    • Design issues in noninferiority/equivalence trials
    • Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Inf. J. 1999 33 : 1205 18.
    • (1999) Drug Inf. J. , vol.33 , pp. 1205-18
    • Hwang, I.K.1    Morikawa, T.2
  • 23
    • 34548381073 scopus 로고    scopus 로고
    • ICH Steering Committee. ICH Harmonized Tripartite Guideline, Statistical Principles for Clinical Trials. Final version, February 1998.
    • ICH Steering Committee. ICH Harmonized Tripartite Guideline, Statistical Principles for Clinical Trials. Final version, February 1998.
  • 24
    • 0037228098 scopus 로고    scopus 로고
    • Effect of variability in Anemia management on hemoglobin outcomes in ESRD
    • Lacson E, Ofsthun N, Lazarus JM. Effect of variability in Anemia management on hemoglobin outcomes in ESRD. Am. J. Kidney Dis. 2003 41 : 111 24.
    • (2003) Am. J. Kidney Dis. , vol.41 , pp. 111-24
    • Lacson, E.1    Ofsthun, N.2    Lazarus, J.M.3
  • 25
    • 84970857770 scopus 로고
    • Regression towards the mean
    • Altman D, Bland M. Regression towards the mean. BMJ 1994 308 : 1499.
    • (1994) BMJ , vol.308 , pp. 1499
    • Altman, D.1    Bland, M.2
  • 26
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the Evaluation of New Treatments
    • Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the Evaluation of New Treatments. Ann. Intern. Med. 2000 133 : 455 63.
    • (2000) Ann. Intern. Med. , vol.133 , pp. 455-63
    • Temple, R.1    Ellenberg, S.S.2
  • 27
    • 0033004225 scopus 로고    scopus 로고
    • Some issues in the design and analysis of equivalence trials
    • Hauck WW, Anderson S. Some issues in the design and analysis of equivalence trials. Drug Inf. J. 1999 33 : 109 18.
    • (1999) Drug Inf. J. , vol.33 , pp. 109-18
    • Hauck, W.W.1    Anderson, S.2
  • 28
    • 0027199595 scopus 로고
    • Clinical and Statistical issues in therapeutic equivalence trials
    • Garbe E, Rohmel J, Gundert-Remy U. Clinical and Statistical issues in therapeutic equivalence trials. Eur. J. Clin. Pharmacol. 1993 45 : 1 7.
    • (1993) Eur. J. Clin. Pharmacol. , vol.45 , pp. 1-7
    • Garbe, E.1    Rohmel, J.2    Gundert-Remy, U.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.