UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028674 |
|---|---|
| Receipt number | R000032403 |
| Scientific Title | A clinical study for TBP-101 (CHDF hemofilter) |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2018/08/16 10:47:29 |
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Basic information
Public title
A clinical study for TBP-101 (CHDF hemofilter)
Acronym
A clinical study for TBP-101 (CHDF hemofilter)
Scientific Title
A clinical study for TBP-101 (CHDF hemofilter)
Scientific Title:Acronym
A clinical study for TBP-101 (CHDF hemofilter)
Region
| Japan |
Condition
Condition
Acute Kidney Injury
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical performance and safety of TBP-101 by conducting CHDF to patients diagnosed with acute kidney injury.
Basic objectives2
Others
Basic objectives -Others
Safety/Clinical Performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Average hours the investigational device is used
2)Adverse events
3)Device deficiencies
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
Perform CRRT by using TBP-101 for 24 hours or more per device.Use 3 investigational devices per patient.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are 20 and over, and under 80.
2)Patients diagnosed with acute kidney injury by using KDIGO definition within 2 days before the first consent.
Key exclusion criteria
1)Patients with disease hard to be treated by CRRT, such as Heparin-Induced Thrombocytopenia (HIT).
2)Patients with anamnesis of allergy symptoms such as anaphylaxis caused by dialyzer, hemofilter et al.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chihiro Ishizuka |
Organization
Toray Industries,Inc.
Division name
Clinical Data Science & Quality Management Dept.
Zip code
Address
1-1, Nihonbashi-muromachi 2-chome, Chuo-ku,Tokyo
TEL
03-3245-8588
Chihiro_Ishizuka@nts.toray.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chihiro Ishizuka |
Organization
Toray Industries, Inc.
Division name
Clinical Data Science & Quality Management Dept.
Zip code
Address
1-1, Nihonbashi-muromachi 2-chome, Chuo-ku,Tokyo
TEL
03-3245-8588
Homepage URL
Chihiro_Ishizuka@nts.toray.co.jp
Sponsor or person
Institute
Toray Industries,Inc.
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
| 2017 | Year | 08 | Month | 15 | 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
| 2017 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032403
| 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 |
