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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029203
Receipt No. R000033381
Scientific Title Development of a new method to control albumin leakage during on-line hemodiafiltration (HDF) therapies for maintenance dialysis patients (New Qs control program of JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA)
Date of disclosure of the study information 2017/09/20
Last modified on 2018/05/22

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Basic information
Public title Development of a new method to control albumin leakage during on-line hemodiafiltration (HDF) therapies for maintenance dialysis patients (New Qs control program of JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA)
Acronym Clinical research to develop the new Qs control program
Scientific Title Development of a new method to control albumin leakage during on-line hemodiafiltration (HDF) therapies for maintenance dialysis patients (New Qs control program of JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA)
Scientific Title:Acronym Clinical research to develop the new Qs control program
Region
Japan

Condition
Condition Chronic Kidney Failure
(End Stage Renal Disease)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a new Qs control program (to regulate amount of albumin leakage) for JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA, and to evaluate the validity of the new program installed in the GC-X01.
Basic objectives2 Others
Basic objectives -Others Performance and safety of the dialysis machine JMS GC-X01 and hemodiafilter ABH-22PA
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Amount of albumin leakage
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 NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Hemodiafiltration therapy using JMS GC-X01 dialysis machine and hemodiafilter ABH-22PA for 8 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 on stable maintenance hemodialysis therapy at least one month on a 3 times per a week schedule with not less than 4 hours per a treatment.
2)Patients corresponding to the following at the time of registration
- Total protein: 5.0 - 7.0 g/dL
- Hematocrit: 28 - 38%.
3)Patients with capable of obtaining blood flow rate >250 mL/min.
4)Patients who are capable to participate in the study as outpatients.
5)Patients capable of understanding the informed consent form.
6)Aged 20 to <80 years at the time of informed consent.
Key exclusion criteria 1)Patients requiring another blood purification therapy such as peritoneal dialysis other than hemodiafiltration within this study period.
2)Patients with a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP).
3)Patients with hypoalbuminemia.
4)Female patients who are or have possibility of pregnant, or breast feeding.
5)Patients who have a history of liver, heart, or lung diseases (ex. Decompensated cirrhosis).
6)Patients with previously untreated malignant tumors.
7)Patients with dementia.
8)Patients having a plan of participating in any other clinical trial within this study period.
9)Patients in the opinion of the principal investigator to disqualify from participation.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Sato
Organization Kaikoukai Medical Foundation
Division name Meiko Kyoritsu Clinic
Zip code
Address 8-202 Kiba-cho, Minato-ku, Nagoya city, Aichi
TEL 052-698-3077
Email t-sato@kaikou.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Taoka
Organization Kaikoukai Medical Foundation
Division name Meiko Kyoritsu Clinic
Zip code
Address 8-202 Kiba-cho, Minato-ku, Nagoya city, Aichi
TEL 052-698-3077
Homepage URL
Email m-taoka@kaikou.or.jp

Sponsor
Institute Kaikoukai Medical Foundation
Meiko Kyoritsu Clinic
Institute
Department

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

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 20 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
Amount of albumin leakage

2points TMP control
Low   (target 2g) 3.58g +/- 0.37g(CV:0.103)
Middle(target 4g) 5.58g +/- 1.54g(CV:0.277)
High  (target 6g) 6.83g +/- 2.67g(CV:0.391)

3points TMP control 
Low   (target 2g) 2.96g +/- 0.68g(CV:0.229)
Middle(target 4g) 6.30g +/- 1.17g(CV:0.186)
High  (target 6g) 7.81g +/- 3.07g(CV:0.393)
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 07 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 20 Day
Last follow-up date
2018 Year 01 Month 05 Day
Date of closure to data entry
2018 Year 01 Month 12 Day
Date trial data considered complete
2018 Year 01 Month 19 Day
Date analysis concluded
2018 Year 01 Month 26 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2018 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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