UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033547
Receipt No. 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 (Ver. 4)

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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
Email 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
Email masa1222@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Integrated Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038254