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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

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ClinicalTrials.gov Identifier: NCT00150566
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 30, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Lanthanum carbonate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment [ Time Frame: 4 & 8 weeks ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 8 weeks ]
  2. Quality of Life [ Time Frame: 8 weeks ]
  3. Subject/physician satisfaction and preference questionnaires [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00150566     History of Changes
Other Study ID Numbers: SPD405-312
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic