UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053267 |
|---|---|
| Receipt number | R000060784 |
| Scientific Title | Clinical evaluation of solute removal properties of hemodiafilter MFX-30UW eco |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/04 18:59:12 |
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Basic information
Public title
Clinical evaluation of solute removal properties of hemodiafilter MFX-30UW eco
Acronym
Clinical evaluation of solute removal properties of hemodiafilter MFX-30UW eco
Scientific Title
Clinical evaluation of solute removal properties of hemodiafilter MFX-30UW eco
Scientific Title:Acronym
Clinical evaluation of solute removal properties of hemodiafilter MFX-30UW eco
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the solute removal characteristics of the hemodiafilters MFX-30UW eco and MFX-30U eco during pre-dilution online HDF. In addition, we evaluate biocompatibility and pressure progression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Removal rate and amount of urea, creatinine, inorganic phosphorus, beta2MG, alpha1MG, albumin, measured at the start of the study and 1 week after changing the hemodiafilter
Key secondary outcomes
Rate of change in White Blood Cell count and Platelet count before and after dialysis, measured at the start of the study and 1 week after changing the hemodiafilter
Transmembrane pressure difference (TMP) and pressure drop during dialysis, measured at the start of the study and 1 week after changing the hemodiafilter
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
Use MFX-30Ueco in the first week, and MFX-30UWeco in the second and third weeks. Blood will be collected before and after the first HDF in the 1st and 3rd week. During the first HDF in the 1st and 3rd week, collect the dialysis effluent every hour and measure the transmembrane pressure difference and pressure drop every hour.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who have undergone online HDF for more than 1 month before obtaining consent
2) Patients who can stably maintain a blood flow rate of 250mL/min
3) Patients using a hemodiafilter with a membrane area of 3.0 m2 or more
4) Patients whose dialysis time is 4 hours or more
5)Patients who are ambulatory
6)Patients who have given written consent to participate in this study
Key exclusion criteria
1) Patients who need to use other blood purification therapies such as peritoneal dialysis that may affect the evaluation of research equipment during research participation.
2)Patients with a past history of acute symptoms such as anaphylactic reactions due to polyethersulfone membrane or polyvinylpyrrolidone (PVP)
3) Patients participating in other clinical studies that may affect the results of this study while participating in the study
4) Those with renal failure due to a serious disease
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yamagishi |
Organization
Yamagishi Nephrology Clinic
Division name
Artificial dialysis department
Zip code
418-0071
Address
135-1 Higashiakoji, Fujinomiya City, Shizuoka Prefecture
TEL
05445213380
takashiy@yamajin-clinic.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yamagishi |
Organization
Yamagishi Nephrology Clinic
Division name
Artificial dialysis department
Zip code
418-0071
Address
135-1 Higashiakoji, Fujinomiya City, Shizuoka Prefecture
TEL
05445213380
Homepage URL
takashiy@yamajin-clinic.com
Sponsor or person
Institute
Yamagishi Nephrology Clinic
Institute
Department
Personal name
Funding Source
Organization
Yamagishi Nephrology Clinic
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 of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel
0534352680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23-247
Org. issuing International ID_1
Ethics Committee of Hamamatsu University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060784
