Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients

Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients - Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033634

Enrollment

Registered

2018-08-06

Start date

2018-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphatemia in chronic kidney disease patients on hemodialysis

Interventions

Switch existing the Ca-containing phoshate binder (precipitated calcium carbonate) to the administration of the non Ca-containing phosphate binder (sucroferric oxyhydroxide) for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: With chronic maintenance dialysis patients (with hemodialysis for more than 3 months from the start of dialysis) Patients who satisfy all the following criteria are targeted. 1)Patients who use precipitated calcium carbonate medication to manage hyperphosphatemia 2)No over 20 years of age and gender 3)Outpatient chronic dialysis patients

Exclusion criteria

Exclusion criteria: Patients who conflict with one of the following are excluded from this study. 1)Patients who have a history of hypersensitivity to the ingredients of sucroferric oxyhydroxide 2)Patients falling under the careful administration of sucroferric oxyhydroxide 3)Patients taking phosphorus binder drugs other than precipitated calcium carbonate 4)Patients taking Lubiprostone 5)Patients receiving antibiotics 6)patients who judged that the doctor in charge is not appropriate

Design outcomes

Primary

Measure	Time frame
the change of serum phosphorus concentration, corrected calcium concentration, serum intact-PTH concentration at the start and after 3 months	—

Secondary

Measure	Time frame
1)State of occurrence of side effects 2)Clinical examination (iron related examination) 3)Defecation status 4)Medication status	—

Countries

Japan

Contacts

Public ContactAoyama Togo

kitasao University, School of Medicine Department of Nephrology

dm02001x@st.kitasato-u.ac.jp042-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026