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

Hyperphosphatemia Clinical Trial

— FOSRENOL-CAPD  

Official title:

Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412398
• Other study ID #: 15076
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: January 18, 2018
• Start date: April 7, 2009
• Est. completion date: September 1, 2016

Study information

• Verified date: January 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: September 1, 2016
• Est. primary completion date: April 8, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in CAPD who have received Fosrenol for hyperphosphatemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions in subjects who received Fosrenol		After Fosrenol administration, up to 1 year
Primary	Incidence of serious adverse events in subjects who received Fosrenol		After Fosrenol administration, up to 1 year
Secondary	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
Secondary	Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]		After Fosrenol administration, up to 1 year
Secondary	Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]		After Fosrenol administration, up to 1 year
Secondary	Clinical test value collections [calciotropic hormones, bone turnover markers]		After Fosrenol administration, up to 1 year

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