UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031337 |
|---|---|
| Receipt number | R000035775 |
| Scientific Title | Oral administration of sucroferric oxyhydroxide during hemodialysis sessions against resistant hyperphosphatemia |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2018/02/16 18:16:43 |
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Basic information
Public title
Oral administration of sucroferric oxyhydroxide during hemodialysis sessions against resistant hyperphosphatemia
Acronym
Sucroferric oxyhydroxide against hyperphosphatemia
Scientific Title
Oral administration of sucroferric oxyhydroxide during hemodialysis sessions against resistant hyperphosphatemia
Scientific Title:Acronym
Sucroferric oxyhydroxide against hyperphosphatemia
Region
| Japan |
Condition
Condition
Resistant hyperphosphatemia in maintenance hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of sucroferric oxyhydroxide during hemdialysis sessions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
reduction of serum phosphate levels
Key secondary outcomes
Serum FGF-23 levels, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of chuwable tablets of sucroferric oxyhydroxide during hemodialysis sessions(1-6T in each session)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Resistant hyperphosphatemia in hemodialysis patients
Key exclusion criteria
patients with risk od aspiration
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Maeda |
Organization
JA Toride Medical Center
Division name
Dialysis center
Zip code
Address
2-1-1 Hingo, Tiride, Ibaraki, Japan
TEL
81-297-74-5551
yoshimaeda43@toride-medical.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Maeda |
Organization
JA Toride Medical Center
Division name
Dialysis Center
Zip code
Address
2-1-1 Hingo, Tiride, Ibaraki, Japan
TEL
81-297-74-5551
Homepage URL
yoshimaeda43@toride-medical.or.jp
Sponsor or person
Institute
Dialysis Center, JA Toride Medical Center
Institute
Department
Personal name
Funding Source
Organization
JA Toride Medical Center
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
Address
Tel
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
JA とりで総合医療センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 16 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035775
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
