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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160121
• Other study ID #: SPD405-401
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2005
• Est. completion date: December 13, 2005

Study information

• Verified date: July 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 13, 2005
• Est. primary completion date: December 13, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Lanthanum carbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

References & Publications (2)

Keith MS, Wilson RJ, Preston P, Copley JB. Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease. Clin Ther. 2014 Sep 1;36(9):1276-86. doi: 10.1016/j.clinthera.2014.06.036. Epub 2014 J — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dialysis serum phosphorus levels at 12 weeks		Week 12
Primary	Patient satisfaction questionnaire at 12 weeks	7 question patient satisfaction questionnaire for participants to respond to how strongly they agree or disagree with their experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.	Week 12
Primary	Physician satisfaction questionnaire at 12 weeks	6 question physician satisfaction questionnaire for physicians to respond to how strongly they agree or disagree with their patient's experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.	Week 12
Primary	Patient preference questionnaire at 12 weeks	6 question patient preference questionnaire for participants to respond to whether they preferred the medication they received during this clinical trial or their previous medication.	Week 12
Primary	Physician preference questionnaire at 12 weeks	7 question physician preference questionnaire for physicians to respond to whether they preferred the medication administered during this clinical trial or their patient's previous medication.	Week 12

External Links

•   FDA Recall Information
•   FDA-approved Label