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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 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 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

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Starting date: March 2009
Last updated: August 18, 2015

Page last updated: August 23, 2015

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