UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050953 |
|---|---|
| Receipt number | R000058078 |
| Scientific Title | PRD-study |
| Date of disclosure of the study information | 2023/04/28 |
| Last modified on | 2023/04/28 15:55:26 |
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Basic information
Public title
Evaluation of Albumin Leakage and a1-MG Removal in Protein-Permeable Dialyzers
Acronym
Evaluation of Albumin Leakage and a1-MG Removal in Protein-Permeable Dialyzers
Scientific Title
PRD-study
Scientific Title:Acronym
PRD-study
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Kawashima Hospital Group has been using albumin leakage and a1-MG removal volume and removal rate as indicators of clinical efficacy in hemodiafiltration therapy, and has previously reported that they are associated with improvement in patient complaints and survival rate. Although the evaluations have been performed under online hemodialysis with hemodiafilter (OHDF), the use of a type II-b protein-permeable dialyzer in HD would enable solute removal in the large molecular weight range similar to that of OHDF.
European RCTs on OHDF discuss treatment conditions only in terms of filtration volume, not in terms of solute removal. On the other hand, our institution has reported that HD and OHDF have equivalent life expectancies when albumin leakage is similar. To elucidate which is responsible for a patient's life expectancy, filtration volume or solute removal, it is important to evaluate solute removal in HD. The purpose of this study is to clarify the albumin leakage rate and the a1-MG removal rate and rate of a1-MG removal in protein-permeable dialyzers, which have not been evaluated so far.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of a1-MG removal rate, a1-MG removal and albumin leakage between PES-25Daeco (dialyzer: Nipro Corporation) and MFX-25U eco (hemodialyzer filter: Nipro Corporation)
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
| Device,equipment |
Interventions/Control_1
Intervention in therapeutic conditions: HD with PES-25Daeco and online HDF with MFX-25U eco (one pre-dilution and one post-dilution), for a total of three treatments, one at a time.
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
Patients on PES-25Daeco or MFX-25U eco
Patients with pre-dialysis serum Alb concentration of 2.9 g/dL or higher
Patients on stable maintenance dialysis
Patients who can maintain a blood flow rate of 280 mL/min
Patients with no access problems (blockage, stenosis, etc.) or puncture difficulties
Patients who can give free and voluntary consent to participate in this study by themselves or by their proxies.
Key exclusion criteria
When consent cannot be obtained.
The physician considers the patient to be unsuitable for participation in this study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yusaku |
| Middle name | |
| Last name | Tanaka |
Organization
Kawashima Hospital
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
6-1 Ichibancho, Kitasako, Tokushima City, Tokushima Prefecture
TEL
088-631-0110
yu-tanaka0724@khg.or.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Tanaka |
Organization
Kawashima Hospital
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
6-1 Ichibancho, Kitasako, Tokushima City, Tokushima Prefecture
TEL
088-631-0110
Homepage URL
yu-tanaka0724@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawashima Hospital
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
Kawashima Hospital
Address
6-1 Ichibancho, Kitasako, Tokushima City, Tokushima Prefecture
Tel
088-631-0110
yu-tanaka0724@khg.or.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
| 2023 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058078
