UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010140 |
|---|---|
| Receipt number | 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 23:20:40 |
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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
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
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011875
