UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008699 |
|---|---|
| Receipt number | R000010225 |
| Scientific Title | Study for new biomarker development in the prediction of renal anemia progression in chronic kidney disease |
| Date of disclosure of the study information | 2012/08/16 |
| Last modified on | 2024/08/26 15:54:16 |
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Basic information
Public title
Study for new biomarker development in the prediction of renal anemia progression in chronic kidney disease
Acronym
Study for new biomarker development in the prediction of renal anemia progression in chronic kidney disease
Scientific Title
Study for new biomarker development in the prediction of renal anemia progression in chronic kidney disease
Scientific Title:Acronym
Study for new biomarker development in the prediction of renal anemia progression 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 angiotensinogen (uAGT) levels and the use of ESA therapy in patients with CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the initiation of ESA therapy, monthly changes of hemoglobin
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
None
Target sample size
90
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
Zip code
Address
2-5-1 Shikata-Cho, Kita-Ward, Okayama,
TEL
0862357235
hitoshis@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sugiyama |
Organization
Okayama University Graduate School of
Division name
Department of Chronic Kidney Disease and
Zip code
Address
2-5-1 Shikatacho Kitaku Okayama, Japan
TEL
0862357235
Homepage URL
hitoshis@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical
Sciences
Institute
Department
Personal name
Funding Source
Organization
1, The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 08 | Month | 16 | 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
| 2007 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2007 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Our study was designed as an objective prospective single-center study to be conducted over a 24-month observational period. It enrolled 95 outpatients with CKD who visited the Division of Nephrology in Okayama University Hospital between March 2009 and December 2011. Demographic characteristics and clinical data were all recorded at the start of the study and two years after. The spot urine samples in the early morning were stored at the enrollment and also at 2 years later. The endpoint of the study was the initiation of ESA therapy by clinical diagnosis of renal anemia by managing nephrologists.
Management information
Registered date
| 2012 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010225
