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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038833
Receipt No. R000044284
Scientific Title Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis
Date of disclosure of the study information 2019/12/09
Last modified on 2019/12/09

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Basic information
Public title Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis
Acronym Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis
Scientific Title Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis
Scientific Title:Acronym Effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on angiogenesis-related proteins in patients undergoing peritoneal dialysis
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of bicarbonate/lactate-buffered neutral peritoneal dialysis fluid on the profile of angiogenesis-related proteins in drained dialysate of patients undergoing PD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes angiogenesis-related proteins in drained dialysate
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
Medicine
Interventions/Control_1 patients were randomly allocated to sequential treatment with L-PDFs following B/L-PDFs(Group A, n=5) or vice versa (Group B, n=5)
Interventions/Control_2 patients were randomly allocated to sequential treatment with L-PDFs following B/L-PDFs(Group A, n=5) or vice versa (Group B, n=5
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with End-stage kidney disease undergoing peritoneal dialysis
Key exclusion criteria Younger than 20 years old
Patients undergoing automated peritoneal dialysis.
Patients with peritonitis
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tetsu
Middle name
Last name Miyamoto
Organization University of Occupational and Environmental Health
Division name Kidney Center
Zip code 807-8555
Address Iseigaoka 1-1, Yahatanishi, Kitakyushu
TEL 093-603-1611
Email tetsum@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name TETSU
Middle name MIYAMOTO
Last name MIYAMOTO
Organization University of Occupational and Environmental Health
Division name Kidney Center
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi
TEL 0936031611
Homepage URL
Email tetsum@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health
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 University of Occupational and Environmental Health
Address Iseigaoka 1-1, Yahatanishi, Kitakyushu
Tel 093-603-1611
Email tetsum@med.uoeh-u.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
2019 Year 12 Month 09 Day

Related information
URL releasing protocol in preparation
Publication of results Unpublished

Result
URL related to results and publications in preparation
Number of participants that the trial has enrolled 10
Results
 In the 19 angiogenesis-related proteins investigated in this study, the expression of growth related oncogene (GRO, CXCL), which belongs to the CXC chemokine family, decreased significantly after use of the B/L-PDFs compared to the L-PDFs (P=0.04). Patients with short-term dialysis vintage tended to have lower levels of angiogenesis-related protein levels when using the B/L-PDFs (P=0.004). 
Results date posted
2019 Year 12 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Four Female, 52-78 yrs old, 4 DM patients 
Participant flow
In 24 PD patients in our department, 14 patients with APD were excluded. 10 patients were enrolled and completed whole protocol.  
Adverse events
None
Outcome measures
 In the 19 angiogenesis-related proteins investigated in this study, the expression of growth related oncogene (GRO, CXCL), which belongs to the CXC chemokine family, decreased significantly after use of the B/L-PDFs compared to the L-PDFs (P=0.04). Patients with short-term dialysis vintage tended to have lower levels of angiogenesis-related protein levels when using the B/L-PDFs (P=0.004). 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 05 Month 07 Day
Anticipated trial start date
2015 Year 05 Month 07 Day
Last follow-up date
2015 Year 10 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
2019 Year 12 Month 09 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044284

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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