Cross-linked iron dextran is an efficient oral phosphate binder in the rat

Abstract

BACKGROUND: There is a need for alternative oral phosphate binders. In-vitro studies showed that iron(III)oxide-hydroxide-modified cross-linked dextran is a promising, insoluble phosphate-binding agent. The present study was designed to assess its in-vivo efficacy and safety in the rat. STUDY, DESIGN AND METHODS: Iron(III)oxide-hydroxide modified dextran beads were mixed with normal rat feed in a proportion of 8% by weight. With this formula rats were fed for 4 weeks. A control group received the same diet without added phosphate binder. Samples of blood, urine, and faeces were taken from each animal before the phosphate binder was administered, 2 weeks later, and at the end of the examination period (day 29). Phosphate, calcium, iron were analysed in the blood samples. Calcium and phosphate concentrations were determined in the urine, phosphate, calcium, and iron concentrations in the excrements. Stability of the material in the duodenum was also simulated. RESULTS AND CONCLUSIONS: The results demonstrate an excellent phosphate-binding capacity of the material and a good tolerance during the intestinal passage. No significant chemical or enzymatic degradation, histological alterations, or other treatment-related macroscopic findings were recorded. The present efficacy and toxicity study has shown effective phosphate binding with no toxicity and no iron release after ingestion of this novel phosphate binding agent. We propose clinical evaluation studies to assess whether similar efficacy and safety can be shown in humans.