Trial Condition(s):
Hyperphosphatemia
Fosrenol post-marketing surveillance for continuous cyclic peritoneal dialysis in Japan (FOSRENOL-CAPD)
Bayer Identifier:
15076
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 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.
Inclusion Criteria
- Patients undergoing continuous ambulatory peritoneal dialysis 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 (investigation for patients with continuous ambulatory peritoneal dialysis)
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 1 year
- Incidence of serious adverse events in subjects who received FosrenolTimeframe: After Fosrenol administration, up to 1 year
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 FosrenolTimeframe: After Fosrenol administration, up to 1 year
- Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]Timeframe: After Fosrenol administration, up to 1 year
- Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]Timeframe: After Fosrenol administration, up to 1 year
- Clinical test value collections [calciotropic hormones, bone turnover markers]Timeframe: After Fosrenol administration, up to 1 year
Additional Information
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