UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033547 |
|---|---|
| Receipt number | R000038254 |
| Scientific Title | Investigation on solute removal efficiency under various treatment conditions in blood purification therapy |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2020/08/06 18:18:13 |
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Basic information
Public title
Investigation on solute removal efficiency under various treatment conditions in blood purification therapy
Acronym
Investigation on solute removal efficiency under various treatment conditions in blood purification therapy
Scientific Title
Investigation on solute removal efficiency under various treatment conditions in blood purification therapy
Scientific Title:Acronym
Investigation on solute removal efficiency under various treatment conditions in blood purification therapy
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In blood purification therapy, by considering drainage sampling and blood collection data under various treatment conditions change, finding the optimum treatment condition considering the solute removal efficiency and the current state
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cr,UN.beta2MG,alpha1MG,Alb,IP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
control
Interventions/Control_2
Change of various treatment conditions
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
We are undergoing blood purification therapy at our hospital
Key exclusion criteria
Death in the middle of research, and transfers.
If you do not obtain consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Yoh |
Organization
Saitama Medical University Integrated Medical Center
Division name
Blood purification center
Zip code
3508550
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL
0492283523
masa1222@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Yoh |
Organization
Saitama Medical University Integrated Medical Center
Division name
Blood purification center
Zip code
3508550
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL
0492283523
Homepage URL
masa1222@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Integrated Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Integrated Medical Center
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
Saitama Medical University Integrated Medical Center
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
Tel
0492283523
masa1222@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
nothing special.
Publication of results
Unpublished
Result
URL related to results and publications
nothing special.
Number of participants that the trial has enrolled
7
Results
In patients with reduced residual renal function, removal of low molecular weight proteins by peritoneal dialysis alone is low, and once-weekly hemodiafiltration in combined hemodiafiltration may be effective in preventing complications.
Results date posted
| 2020 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing blood purification therapy at Saitama Medical University University Medical Center Blood Purification Center.
Participant flow
For the study subjects, the purpose, method, and research cooperation of this study were voluntary using the patient explanation document, that even if they agreed, they could decline on the way and there would be no disadvantage in that case. Will not be used for any purpose other than research purposes, and will be explained orally and in writing about privacy protection. In addition, explain that you can always ask a researcher if you have any questions even after receiving the explanation of this study, dodge the consent form and obtain consent before participating in the study.
Adverse events
nothing special.
Outcome measures
Cr,UN,beta2MG,alpha1MG,Alb,IP,Dialysis circuit internal pressure (measurement items: arterial pressure, venous pressure, dialysate pressure,TMP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038254
