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| |  Once-Monthly Continuous Erythropoietin Receptor Activator Safe Switch for Managing Anaemia in Renal Transplant Patients Taking Erythropoiesis Stimulating Agents: Presented at ATC By Cheryl Lathrop BOSTON -- June 3, 2009 -- Switching to a once-monthly continuous erythropoietin receptor activator (CERA) (methoxy polyethylene glycol-epoetin beta) from shorter-acting erythropoiesis stimulating agents (ESAs) maintains stable haemoglobin levels, and is safe and convenient, according to results of a study presented here at the 2009 American Transplant Congress (ATC). Anaemia is a common complication after a renal transplant and has a negative impact on graft and patient survival. Historically, short-acting ESAs have been the best therapeutic treatment for anaemia in these patients. Methoxy polyethylene glycol-epoetin beta is the first and only CERA; it has a long half-life (approximately 130 hours), allowing for convenient, once-monthly administration. CERA has shown stable haemoglobin maintenance in phase 3 clinical trials, and switching patients from shorter acting ESAs to CERA could be very useful for improving patient quality of life, the research team noted in a poster session here on May 30. Jose Vicente Torregrosa, MD, Josep M. Campistol Renal Transplant Unit, Hospital Clinic, Barcelona, Spain, and colleagues studied the stability and maintenance of haemoglobin serum levels in kidney transplant patients with stable haemoglobin and renal function; all patients were receiving other ESAs before switching to CERA. Dr. Torregrosa's team conducted a prospective, single-arm study of 47 patients (31 female; ages 25 to 79 years) who were all more than 6 months post transplant. The patients either had haemoglobin levels of 11 g/dL or less or were previously treated with ESAs -- 49% had not received previous treatment with an ESA, 34% had been treated with epoetin, and 17% had received darbepoetin alfa. After a 6-month screening period, patients previously treated with epoetin or darbepoetin alfa were switched to once-monthly CERA, administered subcutaneously via prefilled syringes. Patients received 75, 100, or 150 mcg/month, depending on conversion rules set up based on their previous darbepoetin alfa or epoetin dosages. Renal function and haemoglobin values were determined at baseline and then monthly after the switch. Renal function remained stable during the follow-up period, with baseline creatinine levels of 2.4 +- 1.2 mg/dL and final levels of 2.5 +- 1.4 mg/dL (P = nonsignificant). Haemoglobin levels increased during the evaluation period from 10.3 +- 1.0 mg/dL at baseline to 10.8 +- 0.9 mg/dL at month 1 (P < .05), to 11.3 +- 1.3 mg/dL at month 3 (P < .05), and finally to 11.3 +- 1.0 mg/dL at month 6 (P < .05). No adverse events related to CERA were reported. [Presentation title: Evaluation of C.E.R.A. After Correction or Direct Switch From Shorter-Acting ESAs in Kidney Transplant Patients. Abstract 825]
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