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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010140
Receipt No. R000011875
Scientific Title Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Date of disclosure of the study information 2013/02/28
Last modified on 2013/02/28

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Basic information
Public title Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Acronym Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Scientific Title Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Scientific Title:Acronym Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigated the relationship between urinary trefoil factor and the prognosis of renal function in chronic kidney disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the doubling of the serum creatinine, the initiation of dialysis therapy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients
Key exclusion criteria dialysis patients
Target sample size 216

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 Department of Chronic Kidney Disease and Peritoneal Dialysis
Zip code
Address 2-5-1 Shikata-Cho, Kita-Ward, Okayama, Okayama 700-8558, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Chronic Kidney Disease and Peritoneal Dialysis
Zip code
Address 2-5-1 Shikata-Cho, Kita-Ward, Okayama, Okayama 700-8558, Japan
TEL
Homepage URL
Email

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

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 28 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
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We determined the urinary TFF (uTFF) levels using peptide-specific ELISA in human spot urine samples and performed a prospective cohort study. The association between the levels of uTFFs, levels of proteinuria (including albuminuria, beta 2-microglobulin, and NAG, the estimated GFR (eGFR) and the renal prognosis were analyzed during an observation period of three years in 216 CKD patients (mean age: 53.7 years, 47.7% female, 56.9% with chronic glomerulonephritis, 9.7% with nephrosclerosis, mean eGFR: 58.5 ml/min/1.73m2).

Management information
Registered date
2013 Year 02 Month 28 Day
Last modified on
2013 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011875

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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