Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis

The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.

Inclusion Criteria:

• Subjects with ESRD who currently require treatment for hyperphosphatemia
• Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study

Exclusion Criteria:

• Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder
• Hypocalcaemia
• Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL
• Any significant gastrointestinal surgery or gastrointestinal disorders