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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014