Takahara Yuki, Matsuda Yoshimi, Takahashi Shunichi, Shigematsu Takashi
Bayer Yakuhin, Ltd., Osaka, and Division of Nephrology, Department of Internal Medicine, Wakayama Medical University, Wakayama-city, Japan.
Clin Nephrol. 2014 Sep;82(3):181-90. doi: 10.5414/cn108269.
Lanthanum carbonate (LC), an effective non-calcium phosphate binder is widely used to manage hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Recently, the additional indication for control of hyperphosphatemia in CKD patients not on dialysis has been approved.
A multicenter, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of LC in Japanese hyperphosphatemic stage 4 - 5 CKD patients not on dialysis. After a 4-week run-in period, 143 eligible subjects with serum phosphate levels of 5.6 - 11.0 mg/dL were randomized (2 : 1) to receive LC or placebo (88 vs. 55) for 8 weeks; 119 subjects completed the study (76 vs. 43). The starting LC dose was 750 mg/day, which was then up-titrated to 2,250 mg/day as needed while tolerated. Primary efficacy analysis was performed on the intent-to-treat (ITT) population of 141 patients (86 vs. 55).
LC produced a significantly greater reduction in serum phosphate level compared with placebo after 8 weeks of treatment (difference, 0.97 (95% CI: 0.58, 1.37) mg/ dL; p < 0.0001). The cumulative proportion of subjects with controlled phosphate levels ≤ 4.6 mg/dL was higher in the LC group than the placebo group (59.56% vs. 10.46%). LC caused significantly greater reductions in serum Ca × P product and urinary phosphate excretion compared with placebo. The safety profile of LC was similar to that of placebo.
This study demonstrated the effectiveness of LC to control hyperphosphatemia in pre-dialysis CKD patients.
碳酸镧（LC）是一种有效的非钙磷结合剂，广泛用于治疗接受透析的慢性肾脏病（CKD）患者的高磷血症。最近，其在未接受透析的CKD患者中控制高磷血症的额外适应证已获批准。
一项多中心、随机、双盲、安慰剂对照试验，以证实LC在未接受透析的日本4 - 5期高磷血症CKD患者中的疗效和安全性。在为期4周的导入期后，143名血清磷水平为5.6 - 11.0mg/dL的合格受试者被随机分组（2:1），接受LC或安慰剂治疗8周（88例对55例）；119名受试者完成了研究（76例对43例）。LC起始剂量为750mg/天，然后根据耐受情况按需滴定至2250mg/天。对141例患者的意向性治疗（ITT）人群（86例对55例）进行了主要疗效分析。
治疗8周后，与安慰剂相比，LC使血清磷水平显著降低（差值为0.97（95%CI：0.58，1.37）mg/dL；p<0.0001）。磷水平控制在≤4.6mg/dL的受试者累积比例在LC组高于安慰剂组（59.56%对10.46%）。与安慰剂相比，LC使血清钙磷乘积和尿磷排泄显著降低。LC的安全性与安慰剂相似。
本研究证明了LC在透析前CKD患者中控制高磷血症的有效性。
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