UMIN-CTR Clinical Trial

Basic information
Public title	Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients
Acronym	Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients
Scientific Title	Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients
Scientific Title:Acronym	Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients
Region	Japan

Condition
Condition	Hyperphosphatemia in chronic kidney disease patients on hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By changing from a Ca-containing P adsorbent (precipitated calcium carbonate) to a non Ca-containing phosphate adsorbent (sucroferric oxyhydroxide), the following will be clarified. 1) Reveal changes with time of calcium, phosphorus and intact-PTH. 2) Clarify the influence on iron metabolism from change of iron, transferrin saturation, ferritin over time and change of used amount of iron agent and ESA preparation 3) Reveal changes in the status of the stool (Bristol stool scale etc.) and changes in the intestinal flora 4) To clarify the possibility of eliminating polypharmacy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	the change of serum phosphorus concentration, corrected calcium concentration, serum intact-PTH concentration at the start and after 3 months
Key secondary outcomes	1)State of occurrence of side effects 2)Clinical examination (iron related examination) 3)Defecation status 4)Medication status

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Aoyama Middle name Last name Togo
Organization	kitasao University, School of Medicine
Division name	Department of Nephrology
Zip code	2520375
Address	1-15-1, kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Email	dm02001x@st.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Aoyama Middle name Last name Togo
Organization	kitasao University, School of Medicine
Division name	Department of Nephrology
Zip code	2520375
Address	1-15-1, kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	dm02001x@st.kitasato-u.ac.jp

Sponsor
Institute	kitasao University, School of Medicine
Institute
Department

Funding Source
Organization	kitasao University, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University Medical Ethics Organization (KMEO)
Address	1-15-1, kitasato, Minami-ku, Sagamihara, Kanagawa
Tel	042-778-8111
Email	no email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	さがみ循環器クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 15 Day
Date of IRB	2018 Year 07 Month 26 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 06 Day
Last modified on	2020 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037023