title: Efficacy & safety of continuous erythropoietin receptor activator (CERA) in treating renal anaemia in diabetic patients with chronic kidney disease not on dialysis.
abstract: OBJECTIVE
  Chronic kidney disease (CKD) patients on dialysis regularly receive erythropoiesis stimulating agent (ESA) for treating renal anaemia during their dialysis unlike those who are not on dialysis. In such patients, the longer acting ESA can be helpful in reducing their frequent visits to the health care facilities and improving their compliance. This study was aimed to examine the efficacy and safety of continuous erythropoietin receptor activator (CERA), a long acting ESA in treating renal anaemia in patients with diabetic CKD not on dialysis.
  
  
  METHODS
  In this prospective, open-labelled, pilot clinical study, 35 adult type 2 diabetes patients with nephropathy and renal anaemia, who were not on dialysis nor receiving treatment with ESA were administered CERA subcutaneously once in two weeks for a period of 24 weeks. The primary efficacy end point was to evaluate the Hb response (Hb rise of ≥1 g/dl above the baseline or Hb level ≥11 g/dl) during the study period.
  
  
  RESULTS
  All patients showed Hb rise ≥1 g/dl during the study period and 80 per cent patients could achieve Hb value ≥11 g/dl. The maximum median Hb rise of 1.2 g/dl occurred in the initial 6 weeks after starting the treatment. The mean creatinine clearance (CrCl) improved by 2.8 ml/min, with mean Hb rise of 2.6 g/dl from the baseline after administration of CERA. Worsening of blood pressure (BP) control (42.9%) was the most common adverse event.
  
  
  CONCLUSIONS
  CERA once in two weeks was found to be efficacious in correcting anaemia in the ESA-naïve patients with diabetic nephropathy who are not on dialysis. However, regular monitoring of blood pressure is required while on treatment with CERA.
authors.forename: Sameer G
authors.initials: SG
authors.lastname: Vankar
authors.forename: Pinaki
authors.initials: P
authors.lastname: Dutta
authors.forename: H S
authors.initials: HS
authors.lastname: Kohli
authors.affiliation: Department of Endocrinology, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
authors.forename: Anil
authors.initials: A
authors.lastname: Bhansali
mesh_terms: D000328:Adult; D000740:Anemia / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D001794:Blood Pressure; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000473:pathology; D003928:Diabetic Nephropathies / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D004920:Erythropoiesis / Q000187:drug effects; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000188:drug therapy* / Q000473:pathology
chemical_list: C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D011092:Polyethylene Glycols