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
Phase 3
Completed
- Conditions
- Kidney Failure, Chronic
- Registration Number
- NCT00150566
- Lead Sponsor
- Shire
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 460
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment 4 & 8 weeks
- Secondary Outcome Measures
Name Time Method Tolerability 8 weeks Quality of Life 8 weeks Subject/physician satisfaction and preference questionnaires 8 weeks