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 has been completed.

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00150566

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

Drug Information available for: Lanthanum Carbonate

U.S. FDA Resources

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 as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment [ Time Frame: 4 & 8 weeks ]

Secondary Outcome Measures:

Tolerability [ Time Frame: 8 weeks ]
Quality of Life [ Time Frame: 8 weeks ]
Subject/physician satisfaction and preference questionnaires [ Time Frame: 8 weeks ]

Estimated Enrollment:	460
Study Start Date:	February 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

FDA Recall Information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

FDA-approved Label This link exits the ClinicalTrials.gov site

Synopsis of Study Results This link exits the ClinicalTrials.gov site

Study ID Numbers:	SPD405-312
Study First Received:	September 6, 2005
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00150566
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009