UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046398 |
|---|---|
| Receipt number | R000052942 |
| Scientific Title | Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy (NExT-DN) Retrospective Study |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/02/25 21:40:39 |
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Basic information
Public title
Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy (NExT-DN) Retrospective Study
Acronym
NExT-DN Retrospective Study
Scientific Title
Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy (NExT-DN) Retrospective Study
Scientific Title:Acronym
NExT-DN Retrospective Study
Region
| Japan |
Condition
Condition
Diabetic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate novel targets and biomarkers to determinate pathophysiology and prognosis of DKD using human renal tissue, blood, and urine.
Basic objectives2
Others
Basic objectives -Others
To explore the new therapeutic target of DKD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of novel biomerkers and pathophysiological targets in renal tissue, urine, and blood with pathological finding of DKD
Key secondary outcomes
1. Investigation of clinicopathologic indocators of renal progression in diabetic nephropathy
I. eGFR 30-40% decline from baseline
II. eGFR decline > 3-5 ml/min/1.73m2/year
III. Commencement of dialysis or renal transplantation because of end stage renal disease
IV. Development of albuminuric stage
2. Investigation of other major complications of diabetes
I.Development of diabetic retinopathy
II.CVD event
III.Death
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
1. Renal biopsy cohort 1
Patients who agree to join the NExT-DN Study (UMIN000024530) from 2/21/2017 to 12/1/2021
2. Renal biopsy cohort 2
I. Patients who underwent renal biopsy from 12/1/2010 to 2/21/2017 and were diagnosed with kidney disease.
II. Patients who were enrolled into previous clinical studies of our department(No: 1009 and No: 1509-005[2063]).
3. Healthy kidney control
I. Donors of kidney transplantation in our hospital from 7/1/2017 to 12/1/2021
II. Donors without urine abnormalities such as hematuria and proteinuria.
III. Donors who are not diagnosed with any kidney disease in the results of 0 hour-renal biopsy.
IV. Donors who agree to keep their blood and urine sample in OKADAI BIOBANK (Biobank of Okayama university hospital).
Key exclusion criteria
1. Renal biopsy cohort 1
People who decline the entry of NExT-DN Study (UMIN000024530).
2. Renal biopsy cohort 2
Patients who withdraw the agreement of previous clinical studies of our department (No: 1009 and No: 1509-005[2063]).
3. Healthy kidney control
People who decline the entry of this study.
Target sample size
100
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
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)
Other administrative information
Date of disclosure of the study information
| 2022 | 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
100
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
| 2021 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome
Correlation of novel biomerkers and pathophysiological targets in renal tissue, urine, and blood with pathological finding of DKD
Management information
Registered date
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052942
