FOSRENOL-HD: Fosrenol Post-marketing Surveillance for Hemodialysis in Japan
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT01419327
Collaborator
(none)
3,267
1
122.2
26.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
3267 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
Actual Study Start Date
:
Mar 23, 2009
Actual Primary Completion Date
:
Jan 30, 2019
Actual Study Completion Date
:
May 28, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Drug (incl. Placebo) |
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse drug reactions in subjects who received Fosrenol [After Fosrenol administration, up to 8 years]
Secondary Outcome Measures
- Timing of onset of common ADRs related to the priority survey items [After Fosrenol administration, up to 8 years]
The items are Gastrointestinal symptoms Secondary hyperparathyroidism Hypocalcaemia and decreased blood calcium
- 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]
- Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time [After Fosrenol administration, up to 8 years]
- Percentage of patients achieving the serum P control goal [After Fosrenol administration, up to 8 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Japan |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT01419327
Other Study ID Numbers:
- 15077
First Posted:
Aug 18, 2011
Last Update Posted:
May 20, 2020
Last Verified:
May 1, 2020
Keywords provided by Bayer
Additional relevant MeSH terms: