L-Carnitine Treatment in Incident Hemodialysis Patients: The Multicenter, Randomized, Double-Blinded, Placebo-Controlled CARNIDIAL trial

Summary 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. Design, setting, participants, & measurements 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 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.