One Year Efficacy and Safety of Lanthanum Carbonate for Hyperphosphatemia in Japanese Chronic Kidney Disease Patients Undergoing Hemodialysis

Authors

  • Takashi Shigematsu,

    1. Division of Nephrology and Blood Purification Medicine, Department of Medicine, Wakayama Medical University, Wakayama, Japan
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  • Lanthanum Carbonate Research Group

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    • *

      Members of the 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 (New 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); 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); Yoshihiro Tsujimoto, Tsutomu Tabata, Hideki Tahara (Inoue Hospital); and Takeshi Nishiuchi, Takehiko Kimura (Kawashima Cardiovascular Clinic).


Professor Takashi Shigematsu, Wakayama Medical University, 881-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan. Email: taki@wakayama-med.ac.jp

Abstract

Lanthanum carbonate is a non-calcium-based phosphate binder for hyperphosphatemia in patients with chronic kidney disease (CKD). The efficacy and safety of lanthanum carbonate (LaC) on hyperphosphatemia in patients has been well documented in clinical trials in Western countries and recent relatively short-term clinical trials in Japan. Evidence supporting its safety and efficacy in Japanese patients for longer-term treatment is now desired for clinical practice. A non-controlled, open-label, multicenter, one year study of LaC to assess safety and its effect on the levels of serum phosphate, serum calcium and parathyroid hormone was performed with Japanese dialysis patients. Lanthanum carbonate was administered to patients at variable doses for a period of 46–52 weeks. Evaluation of the safety and efficacy of LaC in reducing serum phosphate was performed, in addition to extensive and systematic monitoring of the laboratory parameters related to bone turnover and cardiac health. A significant reduction in the serum phosphate level was demonstrated throughout the treatment period (P < 0.05), without any increase in the frequency or severity of drug-related adverse events such as vomiting, nausea, and stomach discomfort. There was no clinically relevant change in vital signs, or electrocardiograms for a period. The profiles for parathyroid hormone, bone alkaline phosphates, and osteocalcin were stable in the patients concomitantly treated with vitamin D. This study provides further evidence that the administration of LaC over a period of one year is safe and effective for the reduction of serum phosphate levels in CKD patients undergoing hemodialysis.

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