O Hergesell1, E Ritz. 1. Department Internal Medicine, Ruperto Carola University Heidelberg, Germany.
Abstract
BACKGROUND: There is a continuing need for non-aluminium and non-calcium-containing oral phosphate binders. A novel product, i.e. stabilized polynuclear iron hydroxide, has experimentally been shown to be an effective phosphate binder. The purpose of the study was to test the efficacy and tolerability of the compound in hyperphosphataemic patients with stable preterminal renal failure. METHODS: In an open uncontrolled study we examined a total of 13 patients with stable preterminal renal failure (median serum-creatinine 5.4 mg/dl, range 4.2-7.3 mg/dl) and hyperphosphataemia (median fasting plasma-Pi 2.2 mmol/l, range 1.95 3.0 mmol/l). Patients were given dietary advise to maintain a constant intake of phosphate and this was verified by measuring urinary Pi excretion. After 2 weeks on no oral phosphate binders, patients were given daily 3 x 2.5 g stabilized polynuclear iron hydroxide with meals for 4 weeks. In a blinded fashion plasma-Pi and urinary-Pi as well as 1,84 i-PTH, vitamin D metabolites, serum-iron and ferritin were measured in a central laboratory. RESULTS: Compared to baseline (no oral phosphate binders), the median per cent decrease of fasting plasma-Pi at day 14 was 20% (7.2-41%) (P<0.001 by Wilcoxon test) and the median per cent decrease of urinary P excretion was 37% (9.6-56.6%) (P<0.0003 by Wilcoxon test for paired differences). Ferritin levels did not differ significantly during the study. Apart from a certain laxative action and black discolouration of the faeces, no side effects were noted in this short-term study. CONCLUSION: Stabilized polynuclear iron hydroxide is a promising, efficaceous and well tolerated phosphate binder.
BACKGROUND: There is a continuing need for non-aluminium and non-calcium-containing oral phosphate binders. A novel product, i.e. stabilized polynuclear iron hydroxide, has experimentally been shown to be an effective phosphate binder. The purpose of the study was to test the efficacy and tolerability of the compound in hyperphosphataemic patients with stable preterminal renal failure. METHODS: In an open uncontrolled study we examined a total of 13 patients with stable preterminal renal failure (median serum-creatinine 5.4 mg/dl, range 4.2-7.3 mg/dl) and hyperphosphataemia (median fasting plasma-Pi 2.2 mmol/l, range 1.95 3.0 mmol/l). Patients were given dietary advise to maintain a constant intake of phosphate and this was verified by measuring urinary Pi excretion. After 2 weeks on no oral phosphate binders, patients were given daily 3 x 2.5 g stabilized polynuclear iron hydroxide with meals for 4 weeks. In a blinded fashion plasma-Pi and urinary-Pi as well as 1,84 i-PTH, vitamin D metabolites, serum-iron and ferritin were measured in a central laboratory. RESULTS: Compared to baseline (no oral phosphate binders), the median per cent decrease of fasting plasma-Pi at day 14 was 20% (7.2-41%) (P<0.001 by Wilcoxon test) and the median per cent decrease of urinary P excretion was 37% (9.6-56.6%) (P<0.0003 by Wilcoxon test for paired differences). Ferritin levels did not differ significantly during the study. Apart from a certain laxative action and black discolouration of the faeces, no side effects were noted in this short-term study. CONCLUSION: Stabilized polynuclear iron hydroxide is a promising, efficaceous and well tolerated phosphate binder.