Fosrenol Post-marketing Surveillance for Hemodialysis 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: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact: Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
This study is a regulatory post marketing surveillance in Japan, and it is a local
prospective and observational study of patients in hemodialysis who received Fosrenol for
hyperphosphatemia. The objective of this study is to assess safety and efficacy of using
Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5
years.
Clinical Details
Official title: Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
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 collection: calciotropic hormones Clinical test value collection: bone turnover markers
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Japan; Recruiting
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Starting date: March 2009
Last updated: August 18, 2015
|