UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033634 |
|---|---|
| Receipt number | R000037023 |
| Scientific Title | 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 | 2020/02/21 10:05:51 |
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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
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
dm02001x@st.kitasato-u.ac.jp
Sponsor or person
Institute
kitasao University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037023
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| Registered date | File name |
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