DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 weeks

Lab 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017