UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019741 |
|---|---|
| Receipt number | R000022734 |
| Scientific Title | Clinical effects of a peritoneal dialysis fluid with neutral PH , using Automated peritoneal dialysis patients |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2015/11/10 21:30:30 |
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Basic information
Public title
Clinical effects of a peritoneal dialysis fluid with neutral PH , using Automated peritoneal dialysis patients
Acronym
APD with NeutoralPH fluid study
Scientific Title
Clinical effects of a peritoneal dialysis fluid with neutral PH , using Automated peritoneal dialysis patients
Scientific Title:Acronym
APD with NeutoralPH fluid study
Region
| Japan |
Condition
Condition
end stage renal disease patients on peritoneal dialysis therapy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigage the influence of dialysis solution with neutral PH fluid in patients on automated peritoneal dialyhsis therapy,by checking inflamatory marker, oxdative stress mareker and clinical conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
After resistration and 6months after changing dialysate with neutral PH ,inflamatory marker,HsCRP,IL-6,TNF-alfaPrealbumin, Histidine.
Key secondary outcomes
Advanced glycation endproducts both blood and fluid, peritoneal function test, apetite, neutoritional status.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Change dialysate from asid based fluid to neutral PH fluid using Automated peritoneal dialysis machine for 6months.
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
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.under going peritoneal dialysis patients
more than 3 month
2.get informed consent
3.over18 years old. both femal and male
Key exclusion criteria
1.kidney transplantation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Ishida |
Organization
Tokai university Hachioji Hospital
Division name
Nephrology,aEndcrinology and Metabolism
Zip code
Address
1383 ishikawa machi,Hachioji city,Tokyo,Japan
TEL
+81-42-639-1144
marira101213@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Ishida |
Organization
Tokai University Hachioji Hospital
Division name
Nephrology
Zip code
Address
1383 ishikawa machi,Hachioji city,Tokyo,Japan
TEL
+81-42-639-1144
Homepage URL
marira101213@gmail.com
Sponsor or person
Institute
Tokai University Hachioji Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokai University Hachioji Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
BAXTER Limited, Japan
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
北彩都病院 北海道 旭川市
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2015 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022734
