Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

Completed

• Conditions: Hyperphosphatemia

• Registration Number: NCT00567723
• Lead Sponsor: Shire

Brief Summary

Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-25
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Primary Completion: 2016-06-07
• Study Completion: 2016-06-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2105

Inclusion Criteria

Test Group

• Signed informed consent
• Patient must have ESRD and be receiving dialysis
• Prior treatment with Fosrenol for a minimum of 12 consecutive weeks
• Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number)
• Patient must be 18 years of age or older

Exclusion Criteria

Test Group

• Patients that do not meet inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)	5 years

Secondary Outcome Measures

Name	Time	Method
Compare the incidence of selected morbidities among three groups of patients with ESRD	5 years

Trial Locations

Locations (189)

Clinical Research Center, Inc.; 🇺🇸 Birmingham, Alabama, United States

Clinical Research Consultants; 🇺🇸 Hoover, Alabama, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Montgomery Kidney Specialists; 🇺🇸 Montgomery, Alabama, United States

California Kidney Specialist; 🇺🇸 San Dimas, California, United States

Atlantic Avenue Medical Clinic; 🇺🇸 Cudahy, California, United States

East Bay-South Hayward Dialysis Center; 🇺🇸 Hayward, California, United States

Renal Research Center; 🇺🇸 Los Alamitos, California, United States

USC Kidney Center; 🇺🇸 Los Angeles, California, United States

Beverly Nephrology; 🇺🇸 Los Angeles, California, United States

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