UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063398 |
|---|---|
| Receipt number | R000072516 |
| Scientific Title | Comparison of middle-molecule removal characteristics between PMMA (PMF-21A) and polysulfone (ABH-22PA) membranes: a randomized crossover pilot study using beta2-microglobulin, lysozyme and alpha1-microglobulin |
| Date of disclosure of the study information | 2026/10/24 |
| Last modified on | 2026/10/24 17:04:15 |
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Basic information
Public title
Comparison of how well two types of dialysis membranes remove substances from the blood: a study in which each patient uses both membranes in turn
Acronym
Dialysis membrane comparison
Scientific Title
Comparison of middle-molecule removal characteristics between PMMA (PMF-21A) and polysulfone (ABH-22PA) membranes: a randomized crossover pilot study using beta2-microglobulin, lysozyme and alpha1-microglobulin
Scientific Title:Acronym
PMMA vs PS membranes: a crossover pilot
Region
| Japan |
Condition
Condition
End-stage kidney disease on maintenance on-line hemodiafiltration
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the within-patient differences in removal rates of beta2-microglobulin, lysozyme and alpha1-microglobulin, and their variability, between PMMA (PMF-21A) and polysulfone (ABH-22PA) membranes in on-line HDF patients who are not eligible for Lixelle. Clinical symptoms are not evaluated. The estimates will be used to design a future confirmatory trial.
Basic objectives2
Others
Basic objectives -Others
Evaluation of solute removal characteristics of dialysis membranes (estimation of between-membrane differences in removal rates; exploratory pilot study)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Between-membrane difference (PMF-21A minus ABH-22PA) in lysozyme removal rate: Hodges-Lehmann estimate with 95% confidence interval. Timing: calculated from pre- and post-dialysis blood samples at the end of each period (period 1: Nov 9-10; period 2: Dec 7-8).
Key secondary outcomes
(1) Removal rates of beta2-microglobulin and alpha1-microglobulin
(2) Correlations among the removal rates of beta2-microglobulin, lysozyme and alpha1-microglobulin
(3) Period and sequence effects by allocation order (groups X and Y), descriptively
(4) Ultrafiltration volume and replacement fluid volume
(5) Incidence of adverse events (up to 1 week after returning to the original membrane)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group X (n=6): PS membrane ABH-22PA (2.2 m2) in period 1 (2 weeks, about 6 sessions) -> PMMA membrane PMF-21A (2.1 m2) in period 2 (4 weeks) -> return to ABH-22PA after the study. On-line HDF. Dialysis conditions other than the membrane are fixed throughout. Evaluation blood sampling (pre/post dialysis): Nov 9-10 (period 1) and Dec 7-8 (period 2).
Interventions/Control_2
Group Y (n=6): PMMA membrane PMF-21A (2.1 m2) in period 1 (2 weeks, about 6 sessions) -> PS membrane ABH-22PA (2.2 m2) in period 2 (4 weeks). On-line HDF. Dialysis conditions other than the membrane are fixed throughout. Evaluation blood sampling (pre/post dialysis): Nov 9-10 (period 1) and Dec 7-8 (period 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Able to receive on-line HDF stably. (2) Currently using ABH-22PA. (3) Not meeting the criteria for Lixelle, or not using it. (4) Written informed consent obtained after sufficient explanation. (5) No serious complications such as severe infection or malignancy.
Key exclusion criteria
[Exclusion criteria] History of hypersensitivity or allergy to PMMA or polysulfone membranes.
[Discontinuation criteria] Participants will be withdrawn if any of the following occur during the study: (1) serious infection, surgery or hospitalization; (2) change of dialysis conditions (blood flow, dialysate flow, dialysis time, replacement volume); (3) adverse events such as allergy to the membrane; (4) blood sampling difficult for technical reasons; (5) withdrawal of consent.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Kai |
Organization
Shimada Hospital, Jyosuikai Medical Corporation
Division name
Department of Clinical Engineering
Zip code
8600017
Address
24 Renpeimachi, Chuo-ku, Kumamoto-shi, Kumamoto 860-0017, Japan
TEL
0963243515
kai.masanobu@jyosuikai.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Kai |
Organization
Shimada Hospital, Jyosuikai Medical Corporation
Division name
Department of Clinical Engineering
Zip code
8600017
Address
24 Renpeimachi, Chuo-ku, Kumamoto-shi, Kumamoto 860-0017, Japan
TEL
0963243515
Homepage URL
kai.masanobu@jyosuikai.com
Sponsor or person
Institute
Shimada Hospital, Jyosuikai Medical Corporation
Institute
Department
Personal name
Masanobu Kai
Funding Source
Organization
Shimada Hospital, Jyosuikai Medical Corporation
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
Ethics Committee of Shimada Hospital
Address
24 Renpeimachi, Chuo-ku, Kumamoto-shi, Kumamoto 860-0017, Japan
Tel
0963243515
engineer@shimada-hp.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
嶋田病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 24 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 24 | Day |
Last modified on
| 2026 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072516
