UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011082 |
|---|---|
| Receipt number | R000012651 |
| Scientific Title | Exploratory clinical trial of dialysis dose monitor with optical measurement |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2017/07/04 10:24:53 |
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Basic information
Public title
Exploratory clinical trial of dialysis dose monitor with optical measurement
Acronym
Exploratory clinical trial of dialysis dose monitor with optical measurement
Scientific Title
Exploratory clinical trial of dialysis dose monitor with optical measurement
Scientific Title:Acronym
Exploratory clinical trial of dialysis dose monitor with optical measurement
Region
| Japan |
Condition
Condition
End stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the accuracy of the dialysis dose monitor newly developed by Nikkiso Co., Ltd. by measuring correlations blood and the dialysate concentration of solute.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation with urea concentration of dialysis effluent and blood by the dialysis dose monitor
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Dialysis therapy for a week using dialysis machine equipped with the dialysis dose monitor newly developed by Nikkiso Co., Ltd.
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
Stable regular dialysis patients without malnutrition, severe anemia, unstable blood pressure who gives written consent by his/her free will to the participation to the study after receiving sufficient explanation.
Key exclusion criteria
Severe hypertension over systolic pressure of 120 mmHg
Significant recirculation of blood access
Pregnat patients, suspected of being pregnant or lactating patients.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akiba |
Organization
Tokyo Women's Medical University
Division name
Department of Blood Purification
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8112-20251
takiba@kc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isimori Isamu |
Organization
Tokyo Women's Medical University
Division name
Department of Blood Purification
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
ishimori@kc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Department of Blood Purification
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2013 | Year | 08 | Month | 01 | 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
| 2013 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012651
| 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 |
