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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:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00160121
First received: September 8, 2005
Last updated: April 29, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
 Drug: Lanthanum carbonate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • Pre-dialysis serum phosphorus levels at 12 weeks

Secondary Outcome Measures:
  • Physician and patient satisfaction and preference at 12 weeks
  • Lab assessments at 12 weeks

Estimated Enrollment: 2500
Study Start Date: January 2005
Study Completion Date: November 2006
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160121

Sponsors and Collaborators
Shire Development LLC
Investigators
Study Director: Julio Casoy, MD Shire Development LLC
  More Information

Additional 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

No publications provided

ClinicalTrials.gov Identifier: NCT00160121     History of Changes
Other Study ID Numbers: SPD405-401
Study First Received: September 8, 2005
Last Updated: April 29, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013