PMID- 23147696 OWN - NLM STAT- MEDLINE DCOM- 20130513 LR - 20220317 IS - 1421-9670 (Electronic) IS - 0250-8095 (Linking) VI - 36 IP - 5 DP - 2012 TI - Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial. PG - 478-87 LID - 10.1159/000344008 [doi] AB - 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