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Open Access Highly Accessed Research article

Lanthanum carbonate for the treatment of hyperphosphatemia in CKD 5D: multicenter, double blind, randomized, controlled trial in mainland China

Jing Xu1, Yi-Xiang Zhang1, Xue-Qing Yu2, Zhi-Hong Liu3, Li-Ning Wang4, Jiang-Hua Chen5, Ya-Ping Fan6, Zhao-Hui Ni7, Mei Wang8, Fa-Huan Yuan9, Guo-Hua Ding10, Xiang-Mei Chen11, Ai-Ping Zhang12 and Chang-Lin Mei1*

Author Affiliations

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

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BMC Nephrology 2013, 14:29  doi:10.1186/1471-2369-14-29

Published: 4 February 2013

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.

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

Keywords:
Lanthanum carbonate; Hyperphosphatemia; Chronic kidney disease 5D; Hemodialysis; Continuous ambulatory peritoneal dialysis (CAPD)