UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031733 |
|---|---|
| Receipt number | R000036232 |
| Scientific Title | Efficacy and safety of phosphate binders in patients on hemodialysis |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2018/06/05 21:38:48 |
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Basic information
Public title
Efficacy and safety of phosphate binders in patients on hemodialysis
Acronym
Phosphate binders in patients on HD
Scientific Title
Efficacy and safety of phosphate binders in patients on hemodialysis
Scientific Title:Acronym
Phosphate binders in patients on HD
Region
| Japan |
Condition
Condition
Patients undergoing maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects and safety of phosphate binders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum phosphate levels, hepcidin, and FGF23 levels
Key secondary outcomes
Changes in serum iron, TSAT, ferritin levels, hemoglobin concentration, dose of erythropoiesis stimulating agents, and erythropoietin responsiveness index, and safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sucroferric oxyhydroxide or ferric citrate hydrate
Interventions/Control_2
Lanthanum carbonate
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) hemodialysis duration >2 years at enrollment, and (2) hyperphosphatemia that was treated with lanthanum carbonate at least 12 weeks before enrollment.
Key exclusion criteria
(1) a history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months; (2) the presence of infectious disease, malignant tumors, or treatment with steroids or immunosuppressants; (3) current hospitalization
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-cho, Itabsahi-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-cho, Itabsahi-ku, Tokyo, Japan
TEL
03-3972-8311
Homepage URL
totsuki16@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of 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
橋本みなみ内科本院（神奈川県）、優人クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 14 | 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
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | 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=R000036232
| 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 |
