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

• Status: Completed
• Trial end date: 2005-10-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire

Criteria

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