UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055214 |
|---|---|
| Receipt number | R000061663 |
| Scientific Title | AN69HD study |
| Date of disclosure of the study information | 2024/08/10 |
| Last modified on | 2024/08/19 12:24:22 |
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Basic information
Public title
Comparison of efficacy between PS membrane, PMMA membrane and AN69 membrane.in the initial hemodialysis treatment.
Acronym
AN69HD study
Scientific Title
AN69HD study
Scientific Title:Acronym
Comparison of efficacy between PS membrane, PMMA membrane and AN69 membrane.in the initial hemodialysis treatment.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of biocompatibility between PS membrane, PMMA membrane and AN69 membrane in the initial HD session.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intradialytic serum cytokine levels
Key secondary outcomes
dialysis efficasy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions1 : AN69 membrane
Interventions/Control_2
Control 2: PS membrane
Interventions/Control_3
Control 3: PMMA membrane
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
HD induction in our facility
(1) CKD
(2) stage 5
(3) 20 <= age <= 80 y.o at the inclusion.
(4) sex: both
(5) the patients who agree with participate this study
Key exclusion criteria
1, Vascular access surgery within two weeks.
2, Hospitalized within one months except for vascular access surgery
3, have to continue to stay or transfer to another hospital once after HD induction,
4, ACEI is prescribed
5, Patients who is considered to be inappropriate for this study .
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KOJI |
| Middle name | |
| Last name | OKAMOTO |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Nephrology
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai city, Miyagi prefecture, Japan,
TEL
022-717-7392
koji.okamoto.d4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | KOJI |
| Middle name | |
| Last name | OKAMOTO |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Nephrology
Zip code
9808574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai city, Miyagi prefecture
TEL
022-717-7392
Homepage URL
koji.okamoto.d4@tohoku.ac.jp
Sponsor or person
Institute
Department of Nephrology, Tohoku University Graduate School of Medicine
Address: 1-1, Seiryo-cho, Aoba-ku, Sendai city, Miyagi prefecture, Japan,
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 10 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2024 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061663
