Effect of Oral JTT-751 (Ferric Citrate) on Hyperphosphatemia in Hemodialysis Patients: Results of a Randomized, Double-Blind, Placebo-Controlled Trial
Effect of Oral JTT-751 (Ferric Citrate) on Hyperphosphatemia in Hemodialysis Patients: Results of a Randomized, Double-Blind, Placebo-Controlled Trial
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DOI：
10.1159/000344008
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发表时间：
2012-01-01
影响因子：
4.2
通讯作者：
Kumagai, Yuji
中科院分区：
文献类型：
--
作者：
Yokoyama, Keitaro;Hirakata, Hideki;Kumagai, Yuji
背景/目标：JTT-751（柠檬酸铁水合物）是一种新型口服铁基磷酸盐结合剂，正在开发用于治疗慢性肾病透析患者的高磷血症。本研究在日本血液透析患者中调查了JTT-751的剂量反应和安全性。方法：本研究为多中心、随机、安慰剂对照、双盲、平行对照研究。共有192名血清磷（P）水平在6.1和10.0 mg/dl之间的受试者随机接受JTT-751（1.5、3或6 g/天）或安慰剂治疗28天。检查血清P水平较基线的变化。结果如下：在全分析集中，安慰剂组、1.5 g/d组、3 g/d组和6 g/d组第4周血清P水平的平均变化分别为0.04、-1.28、-2.16和-4.10 mg/dl，证明了高达6 g/d的剂量-反应关系。总体而言，血清P水平降低至≥ 50%;然而，认为这不是安全性问题。结论：当血液透析受试者以1.5至6 g/天的剂量接受JTT-751 28天时，血清P水平以剂量依赖性方式显著降低（p < 0.001）。JTT-751被发现是有效和安全的，6克/天组中的大多数受试者的血清P水平达到
Background/Aims: JTT-751 (ferric citrate hydrate) is a novel oral, iron-based phosphate binder being developed for the treatment of hyperphosphatemia among chronic kidney disease patients who are on dialysis. This study investigated the dose-response and safety of JTT-751 among Japanese hemodialysis patients. Methods: This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group, comparative study. A total of 192 subjects with serum phosphorus (P) levels between 6.1 and 10.0 mg/dl were randomized to JTT-751 (1.5, 3 or 6 g/day) or to placebo treatment for 28 days. Changes in serum P level from baseline were examined. Results: In the full analysis set, the mean change in serum P level at week 4 was 0.04, -1.28, -2.16 and -4.10 mg/dl in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively, demonstrating a dose-response relationship up to 6 g/day. Overall, a reduction in serum P levels to = 50%; however, this was not considered to be a safety issue. Conclusions: When hemodialysis subjects received JTT-751 at doses between 1.5 and 6 g/day for 28 days, serum P levels were significantly reduced in a dose-dependent manner (p < 0.001). JTT-751 was found to be efficacious and safe, with the majority of subjects in the 6-grams/day group achieving a serum P level of