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RenaGel (Geltex Pharmaceuticals Inc).

K von Appen1

  • 1Schwerpunkt Nephrologie Medische Klinikum, Klinikum Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany. Kai.vonAppen@lrz.uni-muenchen.de

Idrugs : the Investigational Drugs Journal
|September 15, 2005
PubMed
Summary

RenaGel is a novel polymer effectively binding dietary phosphate in the gut. This treatment offers a new option for managing hyperphosphatemia in patients with chronic renal failure.

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Area of Science:

  • Biochemistry
  • Nephrology
  • Polymer Science

Background:

  • Hyperphosphatemia is a common complication in patients with chronic renal failure.
  • Dietary phosphate restriction is a cornerstone of management but often insufficient.
  • Existing phosphate binders may have limitations.

Purpose of the Study:

  • To evaluate the efficacy and safety of RenaGel for controlling hyperphosphatemia in patients with chronic renal failure.

Main Methods:

  • RenaGel, a non-absorbed polymer, was administered orally to patients with chronic renal failure.
  • Phosphate binding occurred in the intestinal tract.
  • US New Drug Application (NDA) filed and reviewed.

Main Results:

  • US marketing approval granted in November 1998 for hyperphosphatemia control.
  • RenaGel demonstrated effective phosphate binding without systemic absorption.
  • Achieved Part B status in Europe.

Conclusions:

  • RenaGel represents a significant advancement in managing hyperphosphatemia.
  • The polymer offers a novel therapeutic approach for renal failure patients.
  • Projected significant market penetration and sales.

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