UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033983 |
|---|---|
| Receipt number | R000038693 |
| Scientific Title | Identification of novel biomarkers for screening, diagnosis, and prediction of renal prognosis in kidney diseases - Multicenter prospective study - (INSPIRE study) |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/03/03 13:38:58 |
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Basic information
Public title
Identification of novel biomarkers for screening, diagnosis, and prediction of renal prognosis in kidney diseases - Multicenter prospective study - (INSPIRE study)
Acronym
INSPIRE Study
Scientific Title
Identification of novel biomarkers for screening, diagnosis, and prediction of renal prognosis in kidney diseases - Multicenter prospective study - (INSPIRE study)
Scientific Title:Acronym
INSPIRE Study
Region
| Japan |
Condition
Condition
Kidney diseases
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring biomarkers for differenciating kidney diseases
Basic objectives2
Others
Basic objectives -Others
Exploring biomarkers for predicting various prognosis and complications in patients with kideny disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differentiating IgA nephropathy from other renal diseases by using various biomarkers including urinary glycan profiling
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
I. Screening Patients with kidney diseases
Patients with urinary abnormality or impaired renal function at 16 institutions (Okayama university hospital, Okayama Okayama Saiseikai General Hospital, National Hospital Organization Okayama Medical Center, Kurashiki Central Hospital, Japanese Red Cross Okayama Hospital, Japanese Red Cross Society Himeji Hospital, Cugoku Central Hospital, Hiroshima City Hiroshima Citizens Hospital, Onomichi Municipal Hospital, Kousei General Hospital, Ehime Prefectural Central Hospital, Matsuyama Shimin Hospital, Mitoyo General Hospital, Kagawa Prefectural Central Hospital, Kagawa Rosai Hospital, and Kochi Health Sciences Center) between January 2019 and December 2028 will be included.
Impaired renal function is based on the decision of each primary physician.
Estimated glomerular filtration rate [eGFR]< 60 ml/min/1.73m2 is generally included in the criteria, while other parameters such as eGFR decline and relative low levels of eGFR based on age and physical build, can be included the principal.
II. Healthy volunteers
1. Donors of kidney transplantation in our hospital since January 1, 2019
2. Donors without urine abnormalities such as hematuria and proteinuria.
3. Donors who are not diagnosed with any kidney disease in the results of 0 hour-renal biopsy.
4. Donors who agree to keep their blood and urine sample in OKADAI BIOBANK (Biobank of Okayama university hospital).
Key exclusion criteria
People who decline the entry of this study.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Wada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7235
junwada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Mise |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7235
Homepage URL
kokims-frz@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
AMED(Japan Agency for Medical Research and Development)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
GlycoTechnica
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital, Center for Innovative Clinical Medicine, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
Tel
086-235-6503
mae6605@adm.okayama-u.ac.jp
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
岡山大学病院(岡山県)、岡山済生会総合病院(岡山県)、岡山医療センター(岡山県)、倉敷中央病院(岡山県)、岡山赤十字病院(岡山県)、姫路赤十字病院(兵庫県)、中国中央病院(広島県)、広島市民病院(広島県)、尾道市民病院(広島県)、興生総合病院(広島県)、愛媛県立中央病院(愛媛県)、松山市民病院(愛媛県)、三豊総合病院(香川県)、香川県立中央病院(香川県)、香川労災病院(香川県)、高知医療センター(高知県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
I. In patients with renal biopsy and healthy volunteers (Donors of kidney transplantation)
The following investigations are conducted by using urinary and blood samples.
1. Construction of diagnostic algorism of kidney diseases
2. Investigation of prognostic indicators, such as renal prognosis, incidence of cardiovascular disease, and mortality.
3. Investigation of novel biomarkers of renal histopathological findings
II. In patients with screening of kidney diseases.
The following investigations are conducted by using urinary and blood samples.
1. Epidemiologic survey of diagnosis in kidney diseases
2. Comparisons of prognostic values
Management information
Registered date
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038693
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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