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
ClinicalTrials.gov Identifier:
NCT00160121
First received: September 8, 2005
Last updated: December 6, 2013
Last verified: December 2013
  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:


Further study details as provided by Shire:

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
Investigators
Study Director: Julio Casoy, MD Shire
  More Information

Additional Information:
No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00160121     History of Changes
Other Study ID Numbers: SPD405-401
Study First Received: September 8, 2005
Last Updated: December 6, 2013
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 April 22, 2014