Fosrenol Post-marketing Surveillance for Hemodialysis in Japan
FOSRENOL-HD
Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
1 other identifier
observational
3,267
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2019
CompletedMay 20, 2020
May 1, 2020
9.9 years
August 17, 2011
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse drug reactions in subjects who received Fosrenol
After Fosrenol administration, up to 8 years
Secondary Outcomes (7)
Timing of onset of common ADRs related to the priority survey items
After Fosrenol administration, up to 8 years
Effect on bones: Alkaline phosphatase over time
After Fosrenol administration, up to 8 years
Effect on bones: Change in bone density
After Fosrenol administration, up to 8 years
Cardiothoracic ratio over time
After Fosrenol administration, up to 8 years
PWV and ABI over time
After Fosrenol administration, up to 8 years
- +2 more secondary outcomes
Study Arms (1)
Group 1
Drug (incl. Placebo)
Interventions
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.
Eligibility Criteria
The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.
You may qualify if:
- Patients undergoing hemodialysis 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
Related Links
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 17, 2011
First Posted
August 18, 2011
Study Start
March 23, 2009
Primary Completion
January 30, 2019
Study Completion
May 28, 2019
Last Updated
May 20, 2020
Record last verified: 2020-05