check_circleStudy Completed
Hyperphosphatemia
Bayer Identifier:
15076
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Fosrenol post-marketing surveillance for continuous cyclic peritoneal dialysis in Japan
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.
Key Participants Requirements
Sex
BothAge
13 - N/ATrial summary
Enrollment Goal
446Trial Dates
April 2009 - September 2016Phase
Phase 4Could I Receive a placebo
NoProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions in subjects who received Fosrenoldate_rangeTime Frame:After Fosrenol administration, up to 1 yearenhanced_encryptionYesSafety Issue:
- Incidence of serious adverse events in subjects who received Fosrenoldate_rangeTime Frame:After Fosrenol administration, up to 1 yearenhanced_encryptionYesSafety Issue:
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 Fosrenoldate_rangeTime Frame:After Fosrenol administration, up to 1 yearenhanced_encryptionYesSafety Issue:
- Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]date_rangeTime Frame:After Fosrenol administration, up to 1 yearenhanced_encryptionNoSafety Issue:
- Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]date_rangeTime Frame:After Fosrenol administration, up to 1 yearenhanced_encryptionNoSafety Issue:
- Clinical test value collections [calciotropic hormones, bone turnover markers]date_rangeTime Frame:After Fosrenol administration, up to 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A