title: Lanthanum carbonate for the treatment of hyperphosphatemia in CKD 5D: multicenter, double blind, randomized, controlled trial in mainland China.
abstract: BACKGROUND
  Serum phosphorus control is critical for chronic kidney disease (CKD) 5D patients. Currently, clinical profile for an oral phosphorus binder in the mainland Chinese population is not available.
  
  
  OBJECTIVE
  To establish the efficacy, safety, and tolerability of lanthanum carbonate in CKD 5D patients.
  
  
  METHODS
  Multicenter, randomized, double blind, placebo-controlled study. A central randomization center used computer generated tables to allocate treatments.
  
  
  METHODS
  Twelve tertiary teaching hospitals and medical university affiliated hospitals in mainland China.
  
  
  METHODS
  Overall, 258 hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) adult patients were enrolled.
  
  
  METHODS
  After a 0-3-week washout period and a 4-week lanthanum carbonate dose-titration period, 230 patients were randomized 1:1 to receive lanthanum carbonate (1500 mg-3000 mg) or placebo for a further 4-week maintenance phase.
  
  
  METHODS
  Efficacy and safety of lanthanum carbonate to achieve and maintain target serum phosphorus concentrations were assessed.
  
  
  RESULTS
  In the titration phase, serum phosphorus concentrations of all patients decreased significantly. About three-fifths achieved target levels without significantly disturbing serum calcium levels. At the end of the maintenance period, the mean difference in serum phosphorus was significantly different between the lanthanum carbonate and placebo-treated groups (0.63±0.62 mmol/L vs. 0.15±0.52 mmol/L, P < 0.001). The drug-related adverse effects were mild and mostly gastrointestinal in nature.
  
  
  CONCLUSIONS
  Lanthanum carbonate is an efficacious and well-tolerated oral phosphate binder with a mild AE profile in hemodialysis and CAPD patients. This agent may provide an alternative for the treatment of hyperphosphatemia in CKD 5D patients in mainland China.
  
  
  BACKGROUND
  No. ChiCTR-TRC-10000817.
authors: Department of Nephrology, Changzheng Hospital, Second Military Medical University, Shanghai, China.
authors: Jing
authors: J
authors: Xu
authors: Yi-Xiang
authors: YX
authors: Zhang
authors: Xue-Qing
authors: XQ
authors: Yu
authors: Zhi-Hong
authors: ZH
authors: Liu
authors: Li-Ning
authors: LN
authors: Wang
authors: Jiang-Hua
authors: JH
authors: Chen
authors: Ya-Ping
authors: YP
authors: Fan
authors: Zhao-Hui
authors: ZH
authors: Ni
authors: Mei
authors: M
authors: Wang
authors: Fa-Huan
authors: FH
authors: Yuan
authors: Guo-Hua
authors: GH
authors: Ding
authors: Xiang-Mei
authors: XM
authors: Chen
authors: Ai-Ping
authors: AP
authors: Zhang
authors: Chang-Lin
authors: CL
authors: Mei
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China / Q000453:epidemiology; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy* / Q000453:epidemiology*; D007811:Lanthanum / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000453:epidemiology*; D018570:Risk Assessment; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C119467:lanthanum carbonate; D007811:Lanthanum
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