Status:
COMPLETED
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
Lead Sponsor:
Shire
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2004
Trial Type :
INTERVENTIONAL
End Date :
October 8 2005
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00150566
Start Date
February 9 2004
End Date
October 8 2005
Last Update
June 8 2021
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