Lanthanum carbonate for the treatment of hyperphosphatemia in CKD 5D:
multicenter, double blind, randomized, controlled trial in mainland China.
Author(s): Xu J(1), Zhang YX, Yu XQ, Liu ZH, Wang LN, Chen JH, Fan YP, Ni ZH, Wang M, Yuan
FH, Ding GH, Chen XM, Zhang AP, Mei CL.
Affiliation(s): Author information:
(1)Department of Nephrology, Changzheng Hospital, Second Military Medical
University, Shanghai, China.
Publication date & source: 2013, BMC Nephrol. , 14:29
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.
DESIGN: Multicenter, randomized, double blind, placebo-controlled study. A
central randomization center used computer generated tables to allocate
treatments.
SETTING: Twelve tertiary teaching hospitals and medical university affiliated
hospitals in mainland China.
PARTICIPANTS: Overall, 258 hemodialysis or continuous ambulatory peritoneal
dialysis (CAPD) adult patients were enrolled.
INTERVENTION: 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.
MAIN OUTCOME MEASURES: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: No. ChiCTR-TRC-10000817.
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