Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease
Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Chronic
Intervention: Lanthanum carbonate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shire Official(s) and/or principal investigator(s): Julio Casoy, MD, Study Director, Affiliation: Shire
Summary
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pre-dialysis serum phosphorus levels at 12 weeks
Secondary outcome: Physician and patient satisfaction and preference at 12 weeksLab assessments at 12 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
FDA Recall Information
Starting date: January 2005
Last updated: September 3, 2014
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