Sucroferric oxyhydroxide in doses of 750 to 3000 mg per day decreased serum phosphorus levels in a clear, dose-dependent way in Japanese hemodialysis (HD) patients with hyperphosphatemia, researchers report.
In this double-blind, multicenter, phase II study, Fumihiko Koiwa, MD, PhD, of Showa University and Akira Terao, MD, of Josai University in Japan, randomly assigned 183 Japanese HD patients from 14 centers to 6 weeks of treatment with the sucroferric oxyhydroxide (PA21), an iron-based phosphate binder. The drug was given at a dosage of 250, 500, 750, or 1000 mg 3 times per day. Patients with iron overload or abnormally high or low phosphorus levels were excluded from the study.
Results showed that serum phosphorus levels were significantly reduced in each of the sucroferric oxyhydroxide groups compared with placebo. By 6 weeks, more than 80% of patients taking the phosphate binder achieved a target phosphorus level of 6 mg/dL or below.
The phosphate binder also demonstrated a dose-dependent effect. A daily dose of 750 mg or higher reduced average phosphorus levels to 6 mg/dL or below beginning 1 week after treatment. The investigators also noted that a dose of 1500 mg per day or more reduced serum phosphorus to the target of 5.5 mg/dL or below recommended by the Kidney Disease Outcomes Quality Initiative guidelines, starting the first week. Research conducted in the United States and Europe has found daily doses of 1000 to 2500 mg to be effective, they added.
“Therefore, PA21 is useful as a new treatment alternative with a relatively low pill burden for Japanese hemodialysis patients with hyperphosphatemia,” Drs Koiwa and Terao concluded in Clinical and Experimental Nephrology, published online ahead of print. The results generally agree with research in other populations, but they may not apply directly.
Some 14% to 44% of patients taking sucroferric oxyhydroxide reported drug-related side effects such as mild to moderate diarrhea and constipation. With regard to iron absorption, serum ferritin, transferrin saturation, and hemoglobin values rose only slightly with the iron-based phosphate binder.
Future studies comparing sucroferric oxyhydroxide with other phosphate binders are needed. The study authors disclosed fees from Kissei Pharmaceutical Co., Ltd., manufacturers of sucroferric oxyhydroxide in Japan.
1. Koiwa F and Terao A. Dose-response efficacy and safety of PA21 in Japanese hemodialysis patients with hyperphosphatemia: a randomized, placebo-controlled, double-blind, Phase II study. Clin Exp Nephrol. 2017 Jul 7. doi: 10.1007/s10157-016-1299-z. [Epub ahead of print]