UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003138 |
|---|---|
| Receipt number | 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 15:11:35 |
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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
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
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
