Lanthanum carbonate for the treatment of hyperphosphatemia in CKD 5D: multicenter, double blind, randomized, controlled trial in mainland China
1 Department of Nephrology, Changzheng Hospital, Second Military Medical University, Shanghai, China
2 Department of Nephrology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
3 Department of Nephrology, Institute of Kidney Disease of the Chinese People's Liberation Army, Jingling Hospital, Nanjing University School of Medicine, Nanjing, China
4 Department of Nephrology, First Affiliated Hospital of China Medical University, Shenyang, China
5 Kidney Disease Center, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
6 Department of Nephrology, Affiliated Hospital of Nantong Medical College, Jiangsu, China
7 Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
8 Department of Nephrology, People's Hospital of Peking University, Beijing, China
9 Institute of Nephrology of Chongqing and Department of Nephrology, Xinqiao Hospital, Third Military Medical University, Chongqing, China
10 Department of Nephrology, Renmin Hospital of Wuhan University, Wuhan, China
11 Chinese PLA Institute of Nephrology, Chinese PLA General Hospital and Military Medical Postgraduate College, Beijing, China
12 Department of Nephrology, General Hospital of Jinan Military Command, Jinan, Shandong, China
BMC Nephrology 2013, 14:29 doi:10.1186/1471-2369-14-29Published: 4 February 2013
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.
To establish the efficacy, safety, and tolerability of lanthanum carbonate in CKD 5D patients.
Multicenter, randomized, double blind, placebo-controlled study. A central randomization center used computer generated tables to allocate treatments.
Twelve tertiary teaching hospitals and medical university affiliated hospitals in mainland China.
Overall, 258 hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) adult patients were enrolled.
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.
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.
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.