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

Phase 4

Completed

• Conditions: Kidney Failure, Chronic

• Registration Number: NCT00160121
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-10
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Primary Completion: 2005-12-13
• Study Completion: 2005-12-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pre-dialysis serum phosphorus levels at 12 weeks	Week 12
Patient satisfaction questionnaire at 12 weeks	Week 12	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.
Physician satisfaction questionnaire at 12 weeks	Week 12	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.
Patient preference questionnaire at 12 weeks	Week 12	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.
Physician preference questionnaire at 12 weeks	Week 12	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.