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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003138
Receipt No. R000003802
Scientific Title Biomarkers in peritoneal effluents for predicting technique and patient survival in peritoneal dialysis patients
Date of disclosure of the study information 2010/02/03
Last modified on 2011/01/13

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Basic information
Public title Biomarkers in peritoneal effluents for predicting technique and patient survival in peritoneal dialysis patients
Acronym Biomarkers in peritoneal effluents for predicting technique and patient survival in peritoneal dialysis patients
Scientific Title Biomarkers in peritoneal effluents for predicting technique and patient survival in peritoneal dialysis patients
Scientific Title:Acronym Biomarkers in peritoneal effluents for predicting technique and patient survival in peritoneal dialysis patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether elevated free radical levels in peritoneal dialysis effluents increase the risk of both technique failure and patient mortality
Basic objectives2 Others
Basic objectives -Others observational study
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes technique failure and patient mortality within observation period
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Peritoneal dialysis patients with end-stage renal disease
Key exclusion criteria Patients who have peritonitis within 2 months before the study period were excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Sugiyama
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Center for Chronic Kidney Disease and Peritoneal Dialysis
Zip code
Address 2-5-1 Shikata-Cho, Kita-Ward, Okayama City, Okayama
TEL 086-235-7235
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Morinaga
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-Cho, Kita-Ward, Okayama City, Okayama
TEL 086-235-7235
Homepage URL
Email

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Okayama Saiseikai General Hospital
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 岡山済生会総合病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 03 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
2010 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information Prospective cohort study. The level of free radicals in overnight dwell of peritoneal effluent from peritoneal dialysis patients is determined by electron spin resonance (ESR) spectrometer using alpha-phenyl-N-tert butylnitrone (PBN) as a spin trapping agent. The levels of 8-hydroxy-2-deoxyguanosine (8-OHdG), fibrosis-related growth factors (TGF-beta1, VEGF, HGF), and fibronectin are determined using specific ELISA. The levels of L-arginine, ADMA and SDMA are also investigated. The relationships among the biomarkers in PD effluents, daily urine volume, fast PET value, and plasma beta2-microglobulin are also evaluated. The patients will be followed for twenty-four months. The effect of these factors on the composite endpoint (withdrawal from PD or mortality) will be analyzed.

Management information
Registered date
2010 Year 02 Month 03 Day
Last modified on
2011 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003802

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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