UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000519 |
|---|---|
| Receipt number | R000000627 |
| Scientific Title | A prospective study:the clinical value of acidosis correction by acetate free biofiltration (AFB) in hemodialysis patients. |
| Date of disclosure of the study information | 2006/11/30 |
| Last modified on | 2010/05/10 09:38:04 |
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Basic information
Public title
A prospective study:the clinical value of acidosis correction by acetate free biofiltration (AFB) in hemodialysis patients.
Acronym
A prospective study:the clinical value of acidosis correction by acetate free biofiltration (AFB) in hemodialysis patients.
Scientific Title
A prospective study:the clinical value of acidosis correction by acetate free biofiltration (AFB) in hemodialysis patients.
Scientific Title:Acronym
A prospective study:the clinical value of acidosis correction by acetate free biofiltration (AFB) in hemodialysis patients.
Region
| Japan |
Condition
Condition
Dysdialysis syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of acidosis correction target, the safety, and clinical value of acidosis correction by AFB. And elucidate the effectiveness of AFB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
(1)stabilization of circulation dynamics
(2)improvement of QOL
(3)correction of acidosis
(4)rHuEPO dosage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)Hemodiafiltration(HDF)
Interventions/Control_2
2)AFB(bicarbonate high control)
Interventions/Control_3
3)AFB(bicarbonate low control)
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 and a hemodialysis of 4 hours at a time.
Key exclusion criteria
(1)chronic inflammation, malignant disorder, severe respiratory organs and liver disorder, heart failure
(2)20 years or older.
(3)participating in another clinical trial for 12 weeks or longer.
(4)pregnant, during the nursing, possibly pregnant and having the hope of child bearing.
(5)judged inappropriate as study subject by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Akizawa |
Organization
Showa University of Medicine
Division name
Department of Nephrology
Zip code
Address
1-5-8 hatano-dai, sinagawa, tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Honda |
Organization
Showa University of Medicine
Division name
Department of Nephrology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Showa University of Medicine
Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Showa University of Medicine
Department of 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
| 2006 | Year | 11 | Month | 30 | 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
| 2006 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 10 | Day |
Last modified on
| 2010 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000627
