UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029035
Receipt No. R000033200
Scientific Title Evaluation of the removal performance of ABH-22PA when it is used at post-dilution online hemodiafiltration under various dialysis conditions
Date of disclosure of the study information 2017/09/07
Last modified on 2018/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the removal performance of ABH-22PA when it is used at post-dilution online hemodiafiltration under various dialysis conditions
Acronym Evaluation of removal performance of ABH-PA at post-dilution online hemodiafiltration
Scientific Title Evaluation of the removal performance of ABH-22PA when it is used at post-dilution online hemodiafiltration under various dialysis conditions
Scientific Title:Acronym Evaluation of removal performance of ABH-PA at post-dilution online hemodiafiltration
Region
Japan

Condition
Condition Chronic Kidney Failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the removal performance of ABH-22PA when it is used at post-dilution online HDF setting various QB and Qs. In addition, confirm that post-dilution online HDF using ABH-22PA can be performed safety regardless of Qs.
Basic objectives2 Others
Basic objectives -Others Performance, safety
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Reduction rate
2) Removal amount
3) Albumin leakage
4) Transmembrane pressure and Number of alarms
5) Antithrombotic property
6) Adverse events and Device deficiencies
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 Hemodiafiltration using ABH-22PA for 6 weeks
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients who have received hemodiafiltraion using ABH-P or ABH-PA for more than one month at the time of informed consent.
2)Qb 300 mL/min is possible.
3)Outpatients.
4)Ability to understand this research and to give written informed consent.
5)Aged 20 to <80 years at the time of informed consent.
Key exclusion criteria 1)Need to blood purification other than hemodiafiltraion.
2)With a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP).
3)Patients who will participate in other clinical trial during this research.
4)Judged ineligible by the attending physician.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Minakuchi
Organization Kawashima Hospital
Division name Division of Nephrology, Endocrinology
Zip code
Address 1-39 Kitasako Ichiban-cho, Tokushima, Tokushima
TEL 088-631-0110
Email minakuchi_j@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Fujiwara
Organization Wakimachi Kawashima Clinic
Division name Division of clinical engineering
Zip code
Address 39-2 Wakimachi Oaza Inoshiritatejinjashimominami, Mima, Tokushima
TEL 0883-55-0110
Homepage URL
Email we563@hotmail.co.jp

Sponsor
Institute Wakimachi Kawashima Clinic
Institute
Department

Funding Source
Organization ASAHI KASEI MEDICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2017 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 08 Day
Last follow-up date
2017 Year 11 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 07 Day
Last modified on
2018 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033200

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.