Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan

Completed

• Conditions: Hyperphosphatemia
• Interventions: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

• Registration Number: NCT01412398
• Lead Sponsor: Bayer

Brief Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-07
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2014-04-08
• Study Completion: 2016-09-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia

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Exclusion Criteria

• Patients who are contraindicated based on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet	Drug (incl. Placebo)

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subjects who received Fosrenol	After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol	After Fosrenol administration, up to 1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol	After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]	After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]	After Fosrenol administration, up to 1 year
Clinical test value collections [calciotropic hormones, bone turnover markers]	After Fosrenol administration, up to 1 year