Simon D Roger
Affiliation: New South Wales
- Biosimilars: opportunity or cause for concern?Simon D Roger
Department of Renal Medicine, Gosford Hospital, Australia
J Pharm Pharm Sci 10:405-10. 2007..This review focuses on the issues surrounding biosimilars, including manufacturing, quality control, clinical efficacy and side effects, and how government and industry regulations are evolving to deal with these topics...
- Biosimilars: current status and future directionsSimon D Roger
Renal Unit, Gosford Hospital, Holden Street, Gosford, 2250, NSW, Australia
Expert Opin Biol Ther 10:1011-8. 2010..However, there have been concerns over the degree of similarity of these complex drugs in addition to the hope that their introduction may lower the cost of such expensive medicinal products...
- Effects of early and late intervention with epoetin alpha on left ventricular mass among patients with chronic kidney disease (stage 3 or 4): results of a randomized clinical trialSimon D Roger
Department of Renal Medicine, Gosford Hospital, Gosford, Australia
J Am Soc Nephrol 15:148-56. 2004..The maintenance of [Hb] above 100 g/L for many patients in group B might have been attributable to the relative preservation of renal function...
- Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter studyJill S Lindberg
New Orleans Nephrology Associates, 4228 Houma Boulevard, Metairie, LA 70006, USA
J Am Soc Nephrol 16:800-7. 2005..Cinacalcet offers a new therapeutic option for controlling secondary hyperparathyroidism in patients with chronic kidney disease on dialysis...
- Biosimilars: how similar or dissimilar are they?Simon D Roger
Renal Unit, Gosford Hospital, Gosford, New South Wales, Australia
Nephrology (Carlton) 11:341-6. 2006....
- What is the practical conversion dose when changing from epoetin alfa to darbepoetin outside of clinical trials?Simon D Roger
Department of Renal Medicine, Gosford Hospital, Gosford, New South Wales, Australia
Nephrology (Carlton) 9:223-8. 2004..The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. However, this may result in the over treatment of uraemic anaemia...
- Maintenance of elevated versus physiological iron indices in non-anaemic patients with chronic kidney disease: a randomized controlled trialLawrence P McMahon
Department of Renal Medicine, Eastern Health, Melbourne, Victoria, Australia
Nephrol Dial Transplant 25:920-6. 2010..An optimal haemoglobin (Hb) response to erythropoietin requires elevated iron indices in dialysis patients; however, it is unknown if the same applies in chronic kidney disease (CKD)...
- C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysisSimon D Roger
Department of Renal Medicine, Gosford Hospital, Gosford, Australia
Nephrol Dial Transplant 26:3980-6. 2011..E.R.A.) Q4W with darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) for the correction of anaemia in non-dialysis CKD patients...
- A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney diseaseSimon D Roger
Renal Research, Gosford, Australia
Curr Med Res Opin 24:2181-7. 2008..To compare injection site pain of subcutaneous (sc) epoetin beta and darbepoetin alfa in adult patients with chronic kidney disease...
- Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfaSteven Fishbane
Hofstra North Shore Long Island Jewish School of Medicine, Great Neck, NY 11021, USA
Clin J Am Soc Nephrol 8:538-45. 2013..This study evaluated maintenance of hemoglobin levels in patients after conversion from darbepoetin alfa to once-monthly peginesatide...
- Assessment of the bioequivalence of a generic cyclosporine A by a randomized controlled trial in stable renal recipientsAdrian D Hibberd
Newcastle Transplant Unit, Division of Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia
Transplantation 81:711-7. 2006..The aim of this study was to determine the bioequivalence of Cysporin, a generic cyclosporine A, compared with Neoral in stable renal transplant recipients...
- Effect of early correction of anemia on the progression of CKDJerome Rossert
Paris Descartes University, INSERM U652, AP HP, Georges Pompidou European Hospital, Paris, France
Am J Kidney Dis 47:738-50. 2006..This study is designed to assess the effect of early and complete correction of anemia by using recombinant human erythropoietin (epoetin) alfa on the progression of chronic kidney disease (CKD)...
- Epoetin trials: randomised controlled trials don't always mimic observational dataSimon D Roger
Nephrol Dial Transplant 22:684-6. 2007
- Chronic kidney disease, anemia, and epoetinSimon D Roger
N Engl J Med 356:958; author reply 958-9. 2007
- Understanding epoetin use: databases or clinical trials?Simon D Roger
Nephrology (Carlton) 12:118-9. 2007
- Implementing iron management clinical practice guidelines in patients with chronic kidney disease having dialysisMichelle J Irving
Centre for Kidney Research, The Children s Hospital at Westmead, Sydney, NSW, Australia
Med J Aust 185:310-4. 2006..To evaluate the outcomes of and barriers to implementing standard guidelines (Caring for Australasians with renal impairment [CARI]), using iron management in patients having dialysis as an example...
- Clinical correlates and consequences of anemia in a broad spectrum of patients with heart failure: results of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) ProgramEileen O'Meara
Western Infirmary, Glasgow, UK
Circulation 113:986-94. 2006..We wished to determine the prevalence of, potential mechanistic associations of, and clinical outcomes related to anemia in patients with heart failure and a broad spectrum of left ventricular ejection fraction (LVEF)...
- Fistula dysfunction secondary to a subcutaneous myelomatous depositDavid Boshell
Department of Radiology, Westmead Hospital, Sydney, NSW 2031, Australia
Nephrol Dial Transplant 20:2827-9. 2005
- Development, prevention, and potential reversal of left ventricular hypertrophy in chronic kidney diseaseLawrence P McMahon
Department of Nephrology, Western and Royal Melbourne Hospitals, Melbourne, Victoria 3050, Australia
J Am Soc Nephrol 15:1640-7. 2004....
- Epoetin treatment: what are the arguments to expect a beneficial effect on renal disease progression?Jerome Rossert
Nephrol Dial Transplant 17:359-62. 2002