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Recruitment status Completed
Unique ID issued by UMIN UMIN000011765
Receipt No. R000013757
Scientific Title Study of the clinical effects by the central supply method of the acetic acid-free dialytic fluid
Date of disclosure of the study information 2013/09/17
Last modified on 2013/09/14

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Basic information
Public title Study of the clinical effects by the central supply method of the acetic acid-free dialytic fluid
Acronym clinical effects of the acetic acid-free dialytic fluid
Scientific Title Study of the clinical effects by the central supply method of the acetic acid-free dialytic fluid
Scientific Title:Acronym clinical effects of the acetic acid-free dialytic fluid
Region
Japan

Condition
Condition end-stage renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In 2007, first acetic acid-free dialytic fluid (car placard) was released in a country. The car placard has a metabolic acidotic superior correction effect, and the dialysis that National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline "which the HCO3 density should maintain in blood before dialysis of the hemodialysis patient than 22 mEq/L" recommends is possible. We examine an effect to give a clinical response of acetic acid dialytic fluid and the acetic acid-free dialytic fluid in the central supply method and antioxidant ability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes For a hemodialysis patient, we examine a 12-month clinical response of acetic acid-free dialytic fluid after use in acetic acid dialytic fluid for six months. Examination item are dialysis efficiency (Kt/V), a circulation change (mean blood pressure and the pulse), nourishment dialyzing are in a state (serum protein and albumin, nPCR), acidotic improvement effect (pH, HCO3-, BE).
Key secondary outcomes For a hemodialysis patient, we measure a 12-month oxidation stress marker of acetic acid-free dialytic fluid after use in acetic acid dialytic fluid for six months. Examination item are blood reduced glutathione/oxidized glutathione ratio and serum MDA-LDL.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 six months of Acetic acid component dialytic fluid use, and then 12 months of acetic acid-free dialytic fluid use
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria end-stage renal failure patients with stable outpatient maintenance hemodialysis 20 years or older
Key exclusion criteria hemodialysis patients without any cancer or acute Inflammation
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tsuji
Organization National Defense Medical College Hospital
Division name Department of Blood Purification
Zip code
Address 3-2 Namiki, Tokorozawa Saitma, Japan
TEL 04-2995-1511
Email futebol@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Ishizeki
Organization National Defense Medical College Hospital
Division name Department of Blood Purification
Zip code
Address 3-2 Namiki, Tokorozawa Saitma, Japan
TEL 04-2995-1511
Homepage URL
Email halfmoon@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization Non profit foundation
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 防衛医科大学校病院(埼玉県) National Defense Medical College Hospital (Saitama)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 17 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
58th Congress of the Japanese Society for Dialysis therapy 

Acetic acid-free dialytic fluid accepted meaningful improvement of acidotic revision, a nourishment state and anemia. By the long usage of the acetic acid-free dialytic fluid, blood GSH/GSSG was improved significantly, and plasma homocysteine significantly decreased. Thus, an effect to prevent the serious complications in the chronic hemodialysis patient is expected.
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
2010 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2012 Year 06 Month 03 Day
Date of closure to data entry
2012 Year 07 Month 25 Day
Date trial data considered complete
2012 Year 08 Month 05 Day
Date analysis concluded
2012 Year 10 Month 04 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 14 Day
Last modified on
2013 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013757


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