UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032867 |
|---|---|
| Receipt number | R000014893 |
| Scientific Title | Efficacy and safety of sucroferric oxyhydroxide on hemodialysis patients |
| Date of disclosure of the study information | 2018/06/05 |
| Last modified on | 2018/06/05 00:05:33 |
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Basic information
Public title
Efficacy and safety of sucroferric oxyhydroxide on hemodialysis patients
Acronym
Efficacy of sucroferric oxyhydroxide on HD
Scientific Title
Efficacy and safety of sucroferric oxyhydroxide on hemodialysis patients
Scientific Title:Acronym
Efficacy of sucroferric oxyhydroxide on HD
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the efficay nad safetey of sucroferric oxyhydroxide on hemodialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FGF23 levels and anemia-related parameters
Key secondary outcomes
Ca, P, intact-PTH levels
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sucroferric oxyhydroxide
Interventions/Control_2
Lanthanum carbohydrate
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) age > 19 years and < 86 years, (2) hemodialysis duration >6 months at enrollment, and (3) hyperphosphatemia that was treated with lanthanum carbonate at least 12 weeks before enrollment.
Key exclusion criteria
(1) age < 20 years or > 85 years; (2) history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months; (3) presence of infectious disease, malignant tumors, or treatment with steroids or immunosuppressants; (4) current hospitalization; and (5) treatment with ferric citrate hydrate within the past 6 months.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University School of Medicine
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyasu Otsuki |
Organization
Nihon University School of Medicine
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
totsuki16@gmail.com
Sponsor or person
Institute
Department of Nephrology, hypertension and Endocrinology, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nephrology, Hypertension and Endocrinology, Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014893
| 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 |
