title: Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial.
abstract: BACKGROUND
  Lanthanum carbonate (LC), an effective non-calcium phosphate binder is widely used to manage hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Recently, the additional indication for control of hyperphosphatemia in CKD patients not on dialysis has been approved.
  
  
  METHODS
  A multicenter, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of LC in Japanese hyperphosphatemic stage 4 - 5 CKD patients not on dialysis. After a 4-week run-in period, 143 eligible subjects with serum phosphate levels of 5.6 - 11.0 mg/dL were randomized (2 : 1) to receive LC or placebo (88 vs. 55) for 8 weeks; 119 subjects completed the study (76 vs. 43). The starting LC dose was 750 mg/day, which was then up-titrated to 2,250 mg/day as needed while tolerated. Primary efficacy analysis was performed on the intent-to-treat (ITT) population of 141 patients (86 vs. 55).
  
  
  RESULTS
  LC produced a significantly greater reduction in serum phosphate level compared with placebo after 8 weeks of treatment (difference, 0.97 (95% CI: 0.58, 1.37) mg/ dL; p < 0.0001). The cumulative proportion of subjects with controlled phosphate levels ≤ 4.6 mg/dL was higher in the LC group than the placebo group (59.56% vs. 10.46%). LC caused significantly greater reductions in serum Ca × P product and urinary phosphate excretion compared with placebo. The safety profile of LC was similar to that of placebo.
  
  
  CONCLUSIONS
  This study demonstrated the effectiveness of LC to control hyperphosphatemia in pre-dialysis CKD patients.
authors: Bayer Yakuhin, Ltd., Osaka, and Division of Nephrology, Department of Internal Medicine, Wakayama Medical University, Wakayama-city, Japan.
authors: Yuki
authors: Y
authors: Takahara
authors: Yoshimi
authors: Y
authors: Matsuda
authors: Shunichi
authors: S
authors: Takahashi
authors: Takashi
authors: T
authors: Shigematsu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D057194:Intention to Treat Analysis; D007564:Japan; D007811:Lanthanum / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000097:blood*; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications* / Q000175:diagnosis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002614:Chelating Agents; D010710:Phosphates; C119467:lanthanum carbonate; D007811:Lanthanum