title: L-carnitine treatment in incident hemodialysis patients: the multicenter, randomized, double-blinded, placebo-controlled CARNIDIAL trial.
abstract: BACKGROUND
  L-carnitine levels decrease rapidly and steadily with duration of hemodialysis, and carnitine depletion can impair response to recombinant human erythropoietin (rHuEPO). The study hypothesis was that L-carnitine supplementation during the first year of hemodialysis would improve this response.
  
  
  METHODS
  From October 2006 through March 2010, this multicenter, randomized, double-blinded study assigned 92 incident hemodialysis patients to receive placebo or 1 g of intravenous L-carnitine after each dialysis session for 1 year. The primary outcome measure compared the groups for rHuEPO resistance index (EPO-RI), defined as weekly rHuEPO doses (IU/kg body weight divided by hemoglobin level) (g/dl).
  
  
  RESULTS
  In the L-carnitine group, carnitine concentration increased from a mean ± SD of 79 ± 51 µmol/L to 258 ± 137 µmol/L; in the placebo group, it declined from 68 ± 25 µmol/L to 53 ± 24 µmol/L (interaction group × time, P<0.001). Carnitine deficiency affected about 30% of the patients in the placebo group during the study period. EPO-RI varied from 15.8 ± 11.3 to 9.5 ± 5.8 IU/kg per g/dl in the placebo group and from 20.6 ± 12.8 to 15.6 ± 15.9 IU/kg per g/dl in the L-carnitine group, for a mean variation of -3.94 ± 12.5 IU/kg per g/dl and -2.98 ± 15.5 IU/kg per g/dl, respectively (P=0.7). After adjustment for baseline characteristics, the EPO-RI course was similar in each group (difference between groups, P=0.10; interaction group × time, P=0.9).
  
  
  CONCLUSIONS
  Carnitine levels decrease by about 11% ± 33% during the first year of hemodialysis. Treatment of incident hemodialysis patients with L-carnitine does not improve their response to rHuEPO.
authors.affiliation: Nephrology Department, Assistance Publique Hôpitaux de Paris, Pitié Salpétrière Hospital, Paris, France. lucile.mercadal@psl.aphpfr
authors.forename: Lucile
authors.initials: L
authors.lastname: Mercadal
authors.forename: Mathieu
authors.initials: M
authors.lastname: Coudert
authors.forename: Anne
authors.initials: A
authors.lastname: Vassault
authors.forename: Laurence
authors.initials: L
authors.lastname: Pieroni
authors.forename: Alain
authors.initials: A
authors.lastname: Debure
authors.forename: Messaoud
authors.initials: M
authors.lastname: Ouziala
authors.forename: Hélène
authors.initials: H
authors.lastname: Depreneuf
authors.forename: Christine
authors.initials: C
authors.lastname: Fumeron
authors.forename: Aude
authors.initials: A
authors.lastname: Servais
authors.forename: Nader
authors.initials: N
authors.lastname: Bassilios
authors.forename: Jacques
authors.initials: J
authors.lastname: Bécart
authors.forename: Ubald
authors.initials: U
authors.lastname: Assogba
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Allouache
authors.forename: Boussad
authors.initials: B
authors.lastname: Bouali
authors.forename: Nhan
authors.initials: N
authors.lastname: Luong
authors.forename: Marie Paul
authors.initials: MP
authors.lastname: Dousseaux
authors.forename: Sophie
authors.initials: S
authors.lastname: Tezenas-du Montcel
authors.forename: Gilbert
authors.initials: G
authors.lastname: Deray
mesh_terms: D002331:Carnitine / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D004311:Double-Blind Method; D004351:Drug Resistance; D004921:Erythropoietin / Q000627:therapeutic use; D006801:Humans; D015999:Multivariate Analysis; D011994:Recombinant Proteins / Q000627:therapeutic use; D006435:Renal Dialysis
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin; D002331:Carnitine