UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016105 |
|---|---|
| Receipt number | R000018706 |
| Scientific Title | Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI) |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2016/12/17 12:47:46 |
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Basic information
Public title
Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI)
Acronym
Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI)
Scientific Title
Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI)
Scientific Title:Acronym
Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI)
Region
| Japan |
Condition
Condition
Acute kidney injury (AKI)
Classification by specialty
| Nephrology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical effects of CRRT hemofilters with different membrane materials and sizes for the treatment of acute kidney injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
28-day mortality
Key secondary outcomes
60-day mortality.
Changes of SOFA score at 3 and 7 days after CRRT.
Changes of plasma IL-6 levels at 1, 3, and 7 days after CRRT.
Changes of lactate levels at 1, 3, and 7 days after CRRT.
ICU free-days at Day 28.
RRT free-days at Day 28.
Progression to ESRD requiring maintenance hemodialysis.
(subgroup analysis)
septic AKI and non-septic AKI.
with and without endotoxin removal hemoperfusion therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CRRT with 1.8m2 PMMA hemofilter (HEMOFEEL CH-1.8W)
Interventions/Control_2
CRRT with 1.0m2 PMMA hemofilter (HEMOFEEL CH-1.0N)
Interventions/Control_3
CRRT with 1.0m2 Polysulfone hemofilter (EXCELFLO AEF-10)
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
AKI patients (AKIN criteria stage 1 or more) who required CRRT in ICU
Key exclusion criteria
- age less than 18
- pregnant women
- chronic hemodialysis patients or patients who received RRT before randomization
- end stage cancer patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shigematsu |
Organization
Wakayama Medical University
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-441-0639
taki@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Negi |
Organization
Wakayama Medical University
Division name
Division of Nephrology, Department of Inerenal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-441-0639
Homepage URL
shigeon@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Toray Industries, Inc.
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | 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
| 2015 | Year | 01 | Month | 04 | Day |
Last modified on
| 2016 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018706
| 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 |
