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Three-year extension study of lanthanum carbonate therapy in Japanese hemodialysis patients

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Abstract

Background

Lanthanum carbonate is a non-aluminum, non-calcium phosphate binder. Its efficacy and its safety profile up to 1 year have been reported in Japanese hemodialysis patients.

Methods

The present study was an extension of the earlier study. One hundred and forty-five patients were enrolled in the original 1 year observational Phase III study. After 1 year of treatment, 63 patients continued with further lanthanum treatment. Lanthanum carbonate was administered at 750–4,500 mg/day for up to 156 weeks (3 years). The reduction in serum phosphate was used to evaluate efficacy, and laboratory markers of bone turnover were monitored.

Results

The serum phosphate level was maintained at a significantly lower level (P < 0.05) than the baseline level during the 3-year study period. Most of the drug-related adverse events were mild and were mainly gastrointestinal disorders. The safety profile of lanthanum during 3 years of treatment was similar to that seen in the previous study. There were no clinically relevant changes in vital signs or the electrocardiogram. Bone turnover markers, such as osteocalcin, bone-specific alkaline phosphatase, and crosslinked N-telopeptide of type I collagen, showed no clinically relevant changes.

Conclusion

Lanthanum therapy was able to reduce and maintain the serum phosphate level within the K/DOQI and JSDT guideline ranges in Japanese dialysis patients for 3 years.

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Acknowledgments

The authors wish to thank investigators who participated in this study as members of the Lanthanum Carbonate Research group.

Conflict of interest

This study was carried out by Bayer Yakuhin, Ltd. as a GCP Phase III trial. The author (T. Shigematsu MD, Ph.D.) was the principal investigator of this study. The author also received honoraria for Bayer Yakuhin, Ltd. lecture meetings and a research grant from Bayer Yakuhin, Ltd. However, the author has never had any involvement that may raise the question of bias in the work reported or in the conclusions, implications, or opinions stated.

Author information

Authors and Affiliations

  1. Division of Nephrology and Blood Purification Medicine, Department of Medicine, Wakayama Medical University, 881-1 Kimiidera, Wakayama, Wakayama, 641-8509, Japan

    Takashi Shigematsu

Authors
  1. Takashi Shigematsu
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The Lanthanum Carbonate Research Group

Corresponding author

Correspondence to Takashi Shigematsu.

Additional information

The co-investigators in the Lanthanum Carbonate Research Group are listed in the Appendix.

Appendix

Appendix

Co-investigators in Lanthanum Carbonate Research Group

Takehiko Sakai, Masashi Iwasaki, Kazutake Nagakura, Koichi Murakami (Mihama Hospital), Takashi Kono (Mihama Narita Clinic); Ken Ando (Mihama Shizu Clinic); Yasuo Kimura, Junichi Sato (Shin Kashiwa Clinic); Yoshinari Tsuruta, Takaaki Obayashi, Kana Kanashiro (Meiyo Clinic); Hachiro Seno, Yasumitsu Mori, Hiroshi Murai, Naoyuki Nakao (Ama Kyoritsu Clinic); Masafumi Taki, Katsuhiko Arimoto, Tatsuya Matsubara (Shigei Medical Research Hospital); Misaki Moriishi, Hideki Kawanishi, Hiroshi Watanabe (Nakajima Tsutiya Clinic); Jun Minakuchi, Takuma Kato, Ikuro Hayashi, Akihito Kaibara, Kazuhiko Kawahara, Hayato Nishida, Hiroko Suzuki (Kawashima Hospital); Takeshi Nishiuchi, Takehiko Kimura (Kawashima Cardiovascular Clinic); Isao Takeda, Kazunori Kuwahara, Osamu Sugita (Kochi Rehabilitation Hospital); Susumu Miyake, Tomonaga Noguchi (Shimazu Hospital); Kenji Yuasa, Kazumichi Ota, Naotami Terao, Yasukazu Sen, Yoshie Iwasa (Kochi Takasu Hospital); Mari Ishida, Yuji Ishida, Shoko Nakao, Takeshi Kobayashi, Setsuko Yachiku, Chikashi Komura, Naoyuki Yao (Kitasaito Hospital); and Yoshihiro Tsujimoto, Tsutomu Tabata, Hideki Tahara (Inoue Hospital).

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Shigematsu, T., The Lanthanum Carbonate Research Group. Three-year extension study of lanthanum carbonate therapy in Japanese hemodialysis patients. Clin Exp Nephrol 14, 589–597 (2010). https://doi.org/10.1007/s10157-010-0339-3

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  • DOI: https://doi.org/10.1007/s10157-010-0339-3

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