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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150566
First Posted: September 8, 2005
Last Update Posted: April 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shire:

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

Information from the National Library of Medicine

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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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00150566     History of Changes
Other Study ID Numbers: SPD405-312
First Submitted: September 6, 2005
First Posted: September 8, 2005
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