Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.
Not Applicable
Completed
- Conditions
- Hyperphosphatemia in chronic kidney disease patients on hemodialysis
- Registration Number
- JPRN-UMIN000023657
- Lead Sponsor
- Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with a serum ferritin level of 300 ng/mL or more at the latest examination prior to entry 2)Patients with a history of hypersensitivity to the ingredients of sucroferric oxyhydroxide (chewable tablet) 3)Patients who are or may be pregnant or are breast-feeding 4)Patients who are considered inappropriate for participation in this study by the investigator's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy endpoints: 1)Serum phosphate concentration (change in serum phosphate concentration, rate and timing of achievement of target serum phosphate concentration) at each evaluation point 2)Laboratory test data related to red blood cells at each evaluation point 3)Corrected serum calcium concentration at each evaluation point 4)Serum intact-PTH concentration at each evaluation point 5)Ca-P product at each evaluation point 6)FGF23 level at each evaluation point 7)Dose of calcium carbonate at each evaluation point 8)Dose of the study drug at each evaluation point 9)Cumulative dose of ESA during the study drug administration period 10)Cumulative dose of intravenous iron during the study drug administration period Safety endpoints: 1)Adverse events 2)Adverse drug reactions 3)Laboratory test data related to iron at each evaluation point 4)Highly sensitive CRP level at each evaluation point
- Secondary Outcome Measures
Name Time Method