Hyperphosphatemia in chronic kidney disease patients on hemodialysis
Conditions
Interventions
Switch existing drugs for the treatment of hyperphosphatemia to the administration of sucroferric oxyhydroxide TID for 16 weeks.
Sponsors
Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Kawashima Dialysis Clinic, Social Medical Corporation Kawashima Hospital Group Kamoshima Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group Naruto Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group Wakimachi Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group Anan Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have been undergoing hemodialysis (HD or HDF) 3 or more times/week for 12 weeks or longer prior to entry and are scheduled to receive hemodialysis under the same procedures and conditions 2)Patients who have been treated with drugs for hyperphosphatemia other than the study drug at a dose exceeding a specific level for 4 weeks or longer prior to entry 3)Patients with a serum phosphate level of more than 6 mg/dL at the latest examination prior to entry 4)Patients aged 20 years or older at the time of consent 5)Patients who have given written consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkiko Miyajima
Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group General Affairs Section
Outcome results
None listed