UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015891 |
|---|---|
| Receipt number | R000017676 |
| Scientific Title | Study to evaluate the clinical effectiveness of intermittent infusion hemodiafiltration (I-HDF) |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2017/04/27 13:26:39 |
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Basic information
Public title
Study to evaluate the clinical effectiveness of intermittent infusion hemodiafiltration (I-HDF)
Acronym
Study to evaluate the clinical effectiveness of I-HDF
Scientific Title
Study to evaluate the clinical effectiveness of intermittent infusion hemodiafiltration (I-HDF)
Scientific Title:Acronym
Study to evaluate the clinical effectiveness of I-HDF
Region
| Japan |
Condition
Condition
Chronic Kidney Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical condition and quality of life (QOL) of I-HDF compared with HD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
SF-36 ver2
Clinical condition (VAS scale)
Key secondary outcomes
Vital signs (blood pressure, pulse)
Number of treatments by medical staff
Blood test
Dose of erythropoietin-stimulating agent
Solute removal ability
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
HD therapy (for 3 months) --> I-HDF therapy (for 3 months) --> HD therapy (for 3 months)
Interventions/Control_2
I-HDF therapy (for 3 months) --> HD therapy (for 3 months) --> I-HDF therapy (for 3 months)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patient who on-line HDF therapy is possible, and can give written informed consent
- 18 years and over
- Hemodialysis for more than 6 months
Key exclusion criteria
1) Patients with severe cardiovascular disease (NYHA class 3 or 4), hepatic failure, respiratory failure, or malignant tumor
2) 8% or more of the rate of weight gain
3) Patients who are judged ineligible by the attending physician.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Mineshima |
Organization
Tokyo Women's Medical University
Division name
Department of Clinical Engineering
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
mmine@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Sakiyama |
Organization
Tokyo Women's Medical University
Division name
Department of Clinical Engineering
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
sakiyama@twmu.ac.jp
Sponsor or person
Institute
I-HDF Multicenter Study Group
Institute
Department
Personal name
Funding Source
Organization
JMS Co., Ltd.
Asahi Kasei Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
常磐病院（福島県）
名港共立クリニック（愛知県）
偕行会城西病院（愛知県）
偕行会セントラルクリニック（愛知県）
鴨島川島クリニック（徳島県）
鳴門川島クリニック（徳島県）
中島土谷クリニック（広島県）
大町土谷クリニック（広島県）
新古賀クリニック（福岡県）
古賀病院21（福岡県）
伊都クリニック（福岡県）
たかみや医院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 10 | 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
| 2014 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017676
| 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 |
