Trial Condition(s):
Hyperphosphatemia
Fosrenol post-marketing surveillance for hemodialysis in Japan (FOSRENOL-HD)
Bayer Identifier:
15077
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Special drug use investigation of Fosrenol (long-term investigation for patients with hemodialysis)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions in subjects who received FosrenolTimeframe: After Fosrenol administration, up to 8 years
Secondary Outcome
- Timing of onset of common ADRs related to the priority survey itemsThe items are - Gastrointestinal symptoms - Secondary hyperparathyroidism - Hypocalcaemia and decreased blood calciumTimeframe: After Fosrenol administration, up to 8 years
- Effect on bones: Alkaline phosphatase over timeTimeframe: After Fosrenol administration, up to 8 years
- Effect on bones: Change in bone densityTimeframe: After Fosrenol administration, up to 8 years
- Cardiothoracic ratio over timeTimeframe: After Fosrenol administration, up to 8 years
- PWV and ABI over timeTimeframe: After Fosrenol administration, up to 8 years
- Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over timeTimeframe: After Fosrenol administration, up to 8 years
- Percentage of patients achieving the serum P control goalTimeframe: After Fosrenol administration, up to 8 years
Additional Information
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