UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044565 |
|---|---|
| Receipt number | R000050909 |
| Scientific Title | Comparison between online pre-dilution and online post-dilution hemodiafiltration. |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2021/06/16 18:59:56 |
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Basic information
Public title
Comparison between online pre-dilution and online post-dilution hemodiafiltration.
Acronym
Comparison between pre-dilution and post-dilution hemodiafiltration.
Scientific Title
Comparison between online pre-dilution and online post-dilution hemodiafiltration.
Scientific Title:Acronym
Comparison between pre-dilution and post-dilution hemodiafiltration.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Removal characteristics of solutes and safety are compared between pre-HDF and post-HDF.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Removal performances for solutes including BUN, beta2-MG and alpha1-MG, and amount of albumin loss.
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
| Maneuver |
Interventions/Control_1
48L pre-dilution HDF(three times in a week, 2weeks)
8L post-dilution OHDF(2weeks)
Convection volume 10L post-dilution HDF(2weeks)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have been receiving online HDF.
2)Serum albumin concentration will be more than 3.3 g/dL.
3)Patients who will have stable arteriovenous fistula that can get more than 200 mL/min blood flow.
4)Hemodynamics will be stable.
5)Dialysis vintage will be more than 2 years.
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fukuchi |
Organization
ASAMA General Hospital
Division name
Medical department
Zip code
385-0022
Address
1862-1 Iwamurata, Saku-shi, Nagano
TEL
0267-67-2295
satoshi-f@hi.enjoy.ne.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Takahashi |
Organization
ASAMA General Hospital
Division name
Clinical engineering department
Zip code
385-0022
Address
1862-1 Iwamurata, Saku-shi, Nagano
TEL
0267-67-2295
Homepage URL
h-rinsho@city.saku.nagano.jp
Sponsor or person
Institute
ASAMA General Hospital
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
Ethical review board of Asama General Hospital
Address
1862-1 Iwamurata, Saku-shi, Nagano
Tel
0267-67-2295
asama-soumu@city.saku.nagano.jp
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
| 2021 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.umin.ac.jp/ctr/UMIN-CTR_Yougo.htm The information except the description in this site is
Publication of results
Partially published
Result
URL related to results and publications
https://www.umin.ac.jp/ctr/UMIN-CTR_Yougo.htm The information except the description in this site is
Number of participants that the trial has enrolled
6
Results
The 25th annual meeting of Japanese Society for hemodiafiltration
Results in patients treated with 2.1m2 filter (beta2-MG reduction rate, alpha1-MG reduction rate, Alb loss)
48L pre-dilution HDF:79.1%, 21.0%, 3.1g
8L post-dilution HDF:78.7%, 29.2%, 4.3g
Convection volume 10L post-dilution HDF:77.2%, 23.9%, 3.8g
Results in patients treated with 2.6m2 filter
48L pre-dilution HDF:4.1%, 20.0%, 3.6g
8L post-dilution HDF:74.9%, 31.0%, 5.8g
Convection volume 10L post-dilution HDF:73.0%, 21.3%, 3.7g
Results date posted
| 2021 | Year | 06 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
To prepare the paper submission
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050909
