NATIONAL HARBOR, Md.—An investigational iron-based phosphate binder is effective and well tolerated in hemodialysis (HD) patients with hyperphosphatemia, according to data presented at the National Kidney Foundation 2012 Spring Clinical Meetings.

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Michel Chonchol, MD, of the University of Colorado Health Sciences Center in Denver, and colleagues tested the drug PA21 in a randomized, open-label phase 2 trial. In the trial, which compared PA21 with sevelamer hydrochloride, 152 HD patients received a fixed-dose regimen of either PA21 (1.25, 5.0, 7.5, 10.0, or 12.5 g/day) or sevelamer (4.8 g/day) for six weeks.

PA21 dosages of 5.0, 7.5, 10.0, and 12.5 g/day reduced serum phosphorus in a dose-dependent manner. The 5.0 and 7.5 g/day dosages had similar efficacy to sevelamer, whereas the two higher doses of PA21 had greater efficacy. The 5.0 and 7.5 g/day dosages decreased serum phosphorus levels from baseline by a mean of 1.64 and 1.26 mg/dL, respectively, versus a mean 1.47 mg/dL decrease for sevelamer.

The mean decrease in serum phosphorus with the 10.0 and 12.5 g/day dosages of PA21 was 1.86 and 1.87 mg/dL, respectively.

All PA21 doses were well tolerated. Except for hypophosphatemia, the researchers observe no dose-dependent association between PA21 and adverse events. The incidence of hypophosphatemia was greater in the two highest PA21 dose groups (30.8% and 30.4% with 10.0 and 12.5 g/day) than in the 5.0 and 7.5 g/day dose groups (15.4% and and 8.0%, respectively).

In addition, the overall incidence of gastrointestinal AEs was similar for PA21 and sevelamer (23.0% and 23.1%).
The data were presented in poster format at the meeting by investigator James A. Tumlin, MD, of the University of Tennessee College of Medicine in Chattanooga.