Roche Pharmaceuticals

Once-Monthly C.E.R.A. Keeps Haemoglobin Stable in High-Risk Kidney Disease Patients With Diabetes or Heart Disease

    Basel, Switzerland (ots/PRNewswire) - An analysis of two large-scale Phase III maintenance studies on C.E.R.A. has highlighted that two high-risk patient populations - dialysis patients with diabetes and/or coronary artery disease - consistently and safely maintained their haemoglobin (Hb) levels at target levels after direct conversion from more frequently administered epoetin to once-monthly C.E.R.A., a continuous erythropoietin receptor activator. This is a significant outcome as erratic Hb levels have a serious negative impact in these high-risk patients. In addition, being able to effectively control Hb levels with a convenient once-monthly treatment is a further positive outcome.

    "C.E.R.A. was effective in maintaining haemoglobin levels irrespective of the presence or absence of diabetes or coronary artery disease," said Dr Johannes Mann from the KfH Nierenzentrum in Munich, German who presented the new data to delegates at the congress. "This is important news for us since we often see dialysis patients with multiple health conditions where it is critical not to expose them to unnecessary or additional health risks associated with fluctuating haemoglobin levels."

    These award-winning data* were presented for the first time today at the 44th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Barcelona. [1] The investigators set out to examine Hb stability with C.E.R.A. administered once monthly in patients with or without diabetes and coronary artery disease (CAD) (history of angina, myocardial infarction, coronary angioplasty or coronary artery bypass grafting), which represents populations with a poor prognosis. Thirty-five per cent of C.E.R.A. patients in the study had diabetes and 31% had CAD.

    Diabetes is the leading cause of end stage renal disease in the western world [2] [3] and cardiovascular disease is the major cause of death in patients with diabetes[4]; both are frequently present in CKD patients on dialysis either individually or together.

    The Analysis

    Adult patients (832) with stable baseline Hb were randomised in two 52-week, Phase III multi-centre studies (MAXIMA and PROTOS) to receive either IV or SC C.E.R.A. once monthly (415 patients) or to continue with IV or SC epoetin (417 patients) administered once to three times a week. The dose was adjusted no more frequently than once every four weeks to maintain Hb within +/- 1 g/dL of their original baseline value and within a range of 10 - 13.5 g/dL. The change in Hb was investigated in the presence and absence of CAD or diabetes.


    - Mean baseline haemoglobin levels in the C.E.R.A. group with and without diabetes were 11.8 and 11.7 g/dL and with and without coronary artery disease were 11.7 and 11.8 g/dL.

    - During the evaluation period, stable Hb levels were maintained irrespective of the presence or absence of CAD or diabetes.

    - C.E.R.A. had a similar adverse event profile in patients with and without diabetes or coronary artery disease; adverse events were typical of the patient populations.

    About C.E.R.A.

    C.E.R.A., is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin. C.E.R.A. is the only drug to have compared itself in its registration program to three ESAs: epoetin alfa, beta and darbepoetin alfa. C.E.R.A. is not marketed yet, but in May it received an approvable letter from the US FDA and a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing authorisation be granted in the EU.

    About Roche

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    *This abstract, which was granted an oral presentation, was one of three C.E.R.A. abstracts that received the honour of being among the top eight best abstracts received by the congress this year.



    [1] Johannes Mann et al. C.E.R.A. provides stable haemoglobin (Hb) levels in CKD patients on dialysis with and without coronary artery disease (CAD) or diabetes mellitus (DM) when administered once monthly .44th ERA-EDTA Barcelona 2007

    [2] National Kidney Foundation website: Diabetes and Kidney Disease,

    [3] Stevens PE, et al Anaemia in patients with diabetes: unrecognised, undetected and untreated? Cur Med Res Opin 2003; 19 (5) 395-401.

    [4] Levin A. et al. Cardiovascular disease and the kidney; tracking a killer in chronic kidney disease. Postgrad Medicine 2002; 111: 453-60.

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