Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan
FOSRENOL-CAPD
Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
1 other identifier
observational
446
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJanuary 19, 2018
January 1, 2018
5 years
August 4, 2011
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse drug reactions in subjects who received Fosrenol
After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol
After Fosrenol administration, up to 1 year
Secondary Outcomes (4)
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
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]
After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]
After Fosrenol administration, up to 1 year
Clinical test value collections [calciotropic hormones, bone turnover markers]
After Fosrenol administration, up to 1 year
Study Arms (1)
Group 1
Drug (incl. Placebo)
Interventions
Patients in CAPD who have received Fosrenol for hyperphosphatemia
Eligibility Criteria
This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.
You may qualify if:
- Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia
You may not qualify if:
- Patients who are contraindicated based on the product label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 9, 2011
Study Start
April 7, 2009
Primary Completion
April 8, 2014
Study Completion
September 1, 2016
Last Updated
January 19, 2018
Record last verified: 2018-01