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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003194
Receipt No. R000003869
Scientific Title Effectivenss of acetate free dialysate on hemodialysis patients in introduction period: a sigle center open-label prospective randomized controlled study.
Date of disclosure of the study information 2010/02/17
Last modified on 2016/02/16

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Basic information
Public title Effectivenss of acetate free dialysate on hemodialysis patients in introduction period: a sigle center open-label prospective randomized controlled study.
Acronym Acetate free dialysate on hemodialysis patients in introduction period
Scientific Title Effectivenss of acetate free dialysate on hemodialysis patients in introduction period: a sigle center open-label prospective randomized controlled study.
Scientific Title:Acronym Acetate free dialysate on hemodialysis patients in introduction period
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the effect of acetate free dialysate on autonomic function and frequency of arrhythmia, comparing with acetate-containing dialysate in hemodialysis patients in introduction period.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HRV, Plasma catecholamine level, and frequency of arrhythmia are to be measured.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Acetate free dialysate
Interventions/Control_2 Acetate-containing dialysate
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with end stage renal disease and starting hemodialysis at our dialysis unit.
Key exclusion criteria Patients who denied to give consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Tsubakihara
Organization Osaka General Medical Center
Division name Department of Kidney Disease and Hypertension
Zip code
Address 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka City
TEL 06-6692-1201
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Uenoyama
Organization Osaka General Medical Center
Division name Department of Kidney Disease and Hypertension
Zip code
Address 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka City
TEL 06-6692-1201
Homepage URL
Email

Sponsor
Institute Osaka General Medical Center, Department of Kidney Disease and Hypertension
Institute
Department

Funding Source
Organization none
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
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
2010 Year 02 Month 17 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
2009 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 16 Day
Last modified on
2016 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003869

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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