UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000827 |
|---|---|
| Receipt number | R000000992 |
| Scientific Title | Study about efficacy and tolerance of acetate free biofiltration (AFB) in dialysis patients:clinical significance of acetate free and acidisis correction.(NABI study:Nagoya acetate free biofiltration study) |
| Date of disclosure of the study information | 2007/09/28 |
| Last modified on | 2008/06/30 11:54:13 |
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Basic information
Public title
Study about efficacy and tolerance of acetate free biofiltration (AFB) in dialysis patients:clinical significance of acetate free and acidisis correction.(NABI study:Nagoya acetate free biofiltration study)
Acronym
NABI study
Scientific Title
Study about efficacy and tolerance of acetate free biofiltration (AFB) in dialysis patients:clinical significance of acetate free and acidisis correction.(NABI study:Nagoya acetate free biofiltration study)
Scientific Title:Acronym
NABI study
Region
| Japan |
Condition
Condition
Dysdialysis syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the clinical significance on AFB and clinical significance of acetate and acidosis correction by AFB
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ffficacy
(1)circulation stability
(Blood pressure,PWV)
(2)improvement of QOL
(3)clinical significance of acidosis correction
(Ca and Pi metabolism)
(4)clinical significance of Acetate free
(endthelial injury,inflammation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)A:from HDF to AFB
Interventions/Control_2
2) B:from AFB to HDF
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
(1)written informed consent and dysdialysis syndrom.
(2)receive hemodialysis 3 times a week
(3)Iron is controlled enough.(TSAT 20%)
Key exclusion criteria
(1)blood disease, malignant disorder, severe liver disorder
(2) uses steroid, immunosuppression agent
(3) 20 years or older.
(4) participating in another clinical trial for 12 weeks or longer.
(5) pregnant, during the nursing, possibly pregnant and having the hope of child bearing.
(6)judged inappropriate as study subject by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Yuzawa |
Organization
Nagoya University
Division name
Nephrology
Zip code
Address
65 Tsurumai-cho, Shouwa-ku, Nagoya city, Aichi pref. Japan
TEL
052-744-2192
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Morita |
Organization
Nagoya University
Division name
Nephrology
Zip code
Address
65 Tsurumai-cho, Shouwa-ku, Nagoya city, Aichi pref. Japan
TEL
052-744-2192
Homepage URL
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University, Nephrology
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
| 2007 | Year | 09 | Month | 28 | 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
| 2007 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 19 | Day |
Last modified on
| 2008 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000992
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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