UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003194 |
|---|---|
| Receipt number | 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 11:34:30 |
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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
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
Sponsor or person
Institute
Osaka General Medical Center, Department of Kidney Disease and Hypertension
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003869
