Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Shire Identifier:
First received: September 8, 2005
Last updated: September 3, 2014
Last verified: December 2013

September 8, 2005
September 3, 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 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
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Failure, Chronic
Drug: Lanthanum carbonate
Not Provided
Wilson RJ, Keith MS, Preston P, Copley JB. The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease. Adv Ther. 2013 Dec;30(12):1100-10. doi: 10.1007/s12325-013-0077-5. Epub 2013 Dec 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Study Director: Julio Casoy, MD Shire
December 2013

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