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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038254


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name