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Acidulated Phosphate Fluoride Rinse or Gel |
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Clinical Trial: 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
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Kidney Failure, Chronic | Drug: Lanthanum carbonate | Phase III |
MedlinePlus related topics: Kidney Failure
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: 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
Further Study Details:
Primary Outcomes: Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
Secondary Outcomes: Tolerability; Quality of Life; Subject/physician satisfaction and preference questionnaires
Expected Total Enrollment: 460
Secondary Outcomes: Tolerability; Quality of Life; Subject/physician satisfaction and preference questionnaires
Expected Total Enrollment: 460
Study start: February 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
More Information
Study ID Numbers: SPD405-312
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150566
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150566
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Acidulated Phosphate Fluoride Rinse or Gel (Drug Digest)
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