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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperphosphatemia

Intervention: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous cyclic peritoneal dialysis (CCPD) 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 CCPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

Clinical Details

Official title: Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Cyclic Peritoneal Dialysis)

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Incidence of adverse drug reactions in subjects who received Fosrenol

Incidence of serious adverse events in subjects who received Fosrenol

Secondary outcome:

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

Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]

Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]

Clinical test value collections [calciotropic hormones, bone turnover markers]

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients undergoing continuous cyclic peritoneal dialysis who received Fosrenol for

hyperphosphatemia Exclusion Criteria:

- Patients who are contraindicated based on the product label

Locations and Contacts

Many Locations, Japan
Additional Information

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Starting date: April 2009
Last updated: August 10, 2015

Page last updated: August 23, 2015

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