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 FosrenolIncidence 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 FosrenolEffectiveness 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
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