title: Initial use of once-monthly administration of C.E.R.A. is effective and safe in correcting renal anemia in non-dialysis patients: the MERCUR trial.
abstract: BACKGROUND
  Continuous erythropoietin receptor activator (C.E.R.A.) is routinely given once every 2 weeks to correct hemoglobin (Hb) level, but monthly use is recommended in the maintenance phase.
  
  
  METHODS
  In an open-label, single- arm, multicenter trial, 184 ESA-naïve non-dialysis patients with renal anemia (Hb ≤ 10.5 g/dl) received C.E.R.A. monthly from the start of therapy. The trial comprised a titration phase (Months 2 - 7) and an evaluation phase (Months 8 - 9). Mean Hb increased from 9.8 ± 0.7 g/dl at baseline to 11.5 ± 1.1 g/ dl during the evaluation phase (mean change 1.6 ± 1.1 g/dl; 95% CI 1.4 - 1.8 g/dl). Among patients with two Hb values available during the evaluation phase, 18.1% (19/105) were maintained at 11.0 - 12.0 g/dl and 49.5% (52/105) at 11.0 - 13.0 g/dl. 20 patients started dialysis and received C.E.R.A during the titration phase.
  
  
  RESULTS
  Their mean Hb increased from 10.6 ± 1.6 g/dl (last pre-dialysis value) to 11.3 ± 1.6 g/dl. Nine patients (4.9%) experienced one adverse event with a suspected relation to C.E.R.A.; 5 were graded serious. 54 patients (29.3%) discontinued the study (22 for adverse events).
  
  
  CONCLUSIONS
  Although no control arm was included, such that robust comparisons cannot be drawn, these results suggest that C.E.R.A. therapy can be initiated once a month in non-dialysis CKD patients with renal anemia without appearing to compromise the rate or degree of Hb correction.
authors.affiliation: Center of Nephrology, 40822 Mettmann, Germany. koch@dialyse-mettmann.de
authors.forename: Michael
authors.initials: M
authors.lastname: Koch
authors.forename: Dirk
authors.initials: D
authors.lastname: Henrich
authors.forename: Justus
authors.initials: J
authors.lastname: Faust
authors.forename: Jan
authors.initials: J
authors.lastname: Nawka
authors.forename: Thomas
authors.initials: T
authors.lastname: Rath
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D057194:Intention to Treat Analysis; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects*; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000628:therapy; D055815:Young Adult
chemical_list: D006454:Hemoglobins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D011092:Polyethylene Glycols