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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033634
Receipt No. R000037023
Official scientific title of the study Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Prospective clinical study on efficacy and tolerability (examination of gastrointestinal symptoms) of mineral and bone disorder of Sucroferric oxyhydroxide in hemodialysis patients
Title of the study (Brief title) 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 Togo Aoyama
Organization kitasao University, School of Medicine
Division name Department of Nephrology
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 Togo Aoyama
Organization kitasao University, School of Medicine
Division name Department of Nephrology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 15 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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