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

Shire

Status and phase: Completed; Phase 3

Conditions: Kidney Failure, Chronic

Treatments: Drug: Lanthanum carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150566

SPD405-312

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind