UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035705
Receipt number R000040671
Scientific Title Multipotentials of new asymmetric cellulose triacetate membrane for on-line hemodiafiltration both in postdilution and predilution
Date of disclosure of the study information 2019/01/28
Last modified on 2019/04/26 22:21:22

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Basic information

Public title

Multipotentials of new asymmetric cellulose triacetate membrane for on-line hemodiafiltration both in postdilution and predilution

Acronym

Multipotentials of new asymmetric cellulose triacetate membrane for on-line hemodiafiltration both in postdilution and predilution

Scientific Title

Multipotentials of new asymmetric cellulose triacetate membrane for on-line hemodiafiltration both in postdilution and predilution

Scientific Title:Acronym

Multipotentials of new asymmetric cellulose triacetate membrane for on-line hemodiafiltration both in postdilution and predilution

Region

Japan


Condition

Condition

Dialysis patients treated by OL-HDF.
The patient selection criteria required patients to be 20 years or older, but did not concern gender, inpatient/outpatient classification, medical history, or the presence of complications for the patient. We excluded patients with significant inflammatory symptoms and severe impairment of the liver, heart, lungs, etc.

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to elucidate the removal properties of the ATA membrane in OL-HDF compared to those of synthetic polymer membranes as well as examine the influence of the dilution method and substitution volume on the solute removal.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The evaluation items were the removal rate (RR) of B2- microglobulin (B2-MG) and the RR of A1-microglobulin (A1-MG), the removed B2-MG quantity and A1-MG, the albumin leakage quantity, the selective removal index of A1-MG (SRIA), and TMP for each treatment group. The SRIA was calculated as the removed A1-MG quantity divided by the albumin leakage quantity in a single session. We also evaluated the relationship between the removed A1-MG quantity and the albumin leakage quantity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

TDF20-PV (TDF: Toray Medical Co., Ltd.)
The usage period is 4 weeks.

Interventions/Control_2

GDF-21 (GDF: Nikkiso Co., Ltd.)
The usage period is 4 weeks.

Interventions/Control_3

MFX-25U eco (MFX: NIPRO)
The usage period is 4 weeks.

Interventions/Control_4

FIX-250S eco (FIX-S: NIPRO)
The usage period is 4 weeks.

Interventions/Control_5

FIX-250U eco (FIX-U: NIPRO)
The usage period is 4 weeks.

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

The patient selection criteria required patients to be 20 years or older, but did not concern gender, inpatient/outpatient classification, medical history, or the presence of complications for the patient.

Key exclusion criteria

We excluded patients with significant inflammatory symptoms and severe impairment of the liver, heart, lungs, etc.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yusaku
Middle name
Last name Tanaka

Organization

Kawashima Hospital

Division name

Clinical Engineering Department

Zip code

770-0011

Address

1-1-39, Kitasako, Tokushima City, Tokushima Prefecture 770-0011, Japan

TEL

088-631-0110

Email

yu-tanaka0724@khg.or.jp


Public contact

Name of contact person

1st name Yusaku
Middle name
Last name Tanaka

Organization

Kawashima Hospital

Division name

Clinical Engineering Department

Zip code

770-0011

Address

1-1-39, Kitasako, Tokushima City, Tokushima Prefecture 770-0011, Japan

TEL

088-631-0110

Homepage URL


Email

yu-tanaka0724@khg.or.jp


Sponsor or person

Institute

Kawashima Hospital, Clinical Engineering Department

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawashima Hospital

Address

1-1-39, Kitasako, Tokushima City, Tokushima Prefecture, Japan

Tel

088-631-0110

Email

yu-tanaka0724@khg.or.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

2019 Year 01 Month 28 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

Completed

Date of protocol fixation

2019 Year 01 Month 20 Day

Date of IRB

2018 Year 11 Month 01 Day

Anticipated trial start date

2019 Year 01 Month 29 Day

Last follow-up date

2019 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 28 Day

Last modified on

2019 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name