Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 446
- Primary Endpoint
- Incidence of adverse drug reactions in subjects who received Fosrenol
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia
Exclusion Criteria
- •Patients who are contraindicated based on the product label
Arms & Interventions
Group 1
Drug (incl. Placebo)
Intervention: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet (Drug)
Outcomes
Primary Outcomes
Incidence of adverse drug reactions in subjects who received Fosrenol
Time Frame: After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol
Time Frame: After Fosrenol administration, up to 1 year
Secondary Outcomes
- 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)