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Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00160121
First Posted: September 12, 2005
Last Update Posted: September 5, 2014
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
September 8, 2005
September 12, 2005
September 5, 2014
January 2005
Not Provided
Pre-dialysis serum phosphorus levels at 12 weeks
Same as current
Complete list of historical versions of study NCT00160121 on ClinicalTrials.gov Archive Site
  • Physician and patient satisfaction and preference at 12 weeks
  • Lab assessments at 12 weeks
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease
A Phase IV, Open-Label, Multi-Center Trial Evaluating the Efficacy of Fosrenol Compared to Existing Therapy in Adults With End Stage Renal Disease Treated for Hyperphosphatemia
The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Failure, Chronic
Drug: Lanthanum carbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2500
November 2006
Not Provided

Inclusion Criteria:

  • Patients with ESRD who currently require treatment for hyperphosphatemia

Exclusion Criteria:

  • Female patient who is pregnant or lactating
  • Patient has used any investigational product within 30 days of screening
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00160121
SPD405-401
Not Provided
Not Provided
Not Provided
Not Provided
Shire
Not Provided
Study Director: Julio Casoy, MD Shire
Shire
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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