Continuous EPO receptor activator therapy of anemia in children under peritoneal dialysis
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ORIGINAL ARTICLE
Continuous EPO receptor activator therapy of anemia in children under peritoneal dialysis Francisco Cano & Claudia Alarcon & Marta Azocar & Carolina Lizama & Ana Maria Lillo & Angela Delucchi & Mariluz Gonzalez & Patricia Arellano & Iris Delgado & Maria Teresa Droguett
Received: 14 November 2010 / Revised: 8 February 2011 / Accepted: 22 February 2011 / Published online: 18 March 2011 # IPNA 2011
Abstract The short half-life of erythropoietin (rHuEPO) leads to repeated fluctuations in hemoglobin levels and the need for frequent administration. Continuous erythropoietin receptor activator (CERA) therapy has been approved for once or twice a month in adult dialysis patients. To evaluate the efficacy and safety of CERA therapy in the management of anemia in pediatric peritoneal dialysis (PD) stable PD children under twice-a-week EPO were converted to a subcutaneous CERA, scheduled every 2 weeks. The follow-up was 6 months. The primary efficacy parameter was hemoglobin >11 g/dL. The exclusion criteria were ferritin 20%. Patients were excluded if they had received RBC in the previous 12 weeks of the study, or had a nonrenal cause of anemia, such as hemolysis, hemoglobinopathy, and others. Maximum Hb level was not considered an exclusion criteria. Other exclusion criteria were C-reactive protein level greater than 30 mg/L, hypertension (BP > 90th percentile), gastrointestinal bleeding; parathyroid hormone level >700 pg/mL; active systemic infection; a peritonitis episode within 30 days of signing the consent/assent, and previous poor compliance. Patients were retired from the study if poor compliance or two missing Hb values were confirmed. Compliance was defined as the extent to which the patient’s or their parent’s behavior, in terms of taking medications, following diets, or executing lifestyle changes, coincided with medical and nursing advice. The design was approved by the Ethics Committee of the Faculty of Medicine, University of Chile, Luis Calvo Mackenna Children’s Hospital. All participants gave prior written informed consent/assent, as requested by the Committee. Procedures Eligible patients were switched to methoxy polyethylene glycol epoetin beta starting at a mean dose of 0.5 μg/kg every 2 weeks, according to published experiences in adults with CKD [18–20]. Patients were assessed every 2 weeks for the first 3 months, and later monthly during the 6-month followup period. Hemoglobin, hematocrit, electrolytes, blood gases, plasma albumin, creatinine, and BUN were measured at each assessment visit. Reticulocyte index (reticulocyte count × (HCT/normal HCT)) was calculated at each visit. Parathormone, ferritin, transferrin saturation, biochemical profile and dialysis dose (Kt/V) were measured every 2 months until the final visit (week 24). All patients had a peritoneal equilibrium test (PET) prior to and after the protocol. A clinical evaluation including weight standard deviation scores (SDS), height SDS, and blood pressure was performed at each visit. Patients received i.v. iron 2 mg/kg/week f
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