UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024530 |
|---|---|
| Receipt number | R000028235 |
| Scientific Title | Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy Study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/05/08 18:10:51 |
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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 Study
Acronym
NExT-DN
Scientific Title
Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy Study
Scientific Title:Acronym
NExT-DN
Region
| Japan |
Condition
Condition
Diabetes
Diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate new prognostic and diagnostic indicators of diabetic nephropathy
Basic objectives2
Others
Basic objectives -Others
To explore the new therapeutic target of diabetic nephropathy
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
eGFR 30-40% decline from baseline
Key secondary outcomes
1. Investigation of clinicopathologic indocators of renal progression in diabetic nephropathy
I. eGFR decline > 3-5 ml/min/1.73m2/year
II. Commencement of dialysis or renal transplantation because of end stage renal disease
III. Development of albuminuric stage
2. Investigation of other major complications of diabetes
I.Development of diabetic retinopathy
II.CVD event
III.Death
3. Exploration of new biomarkers to predict diabetic nephropathy in patients with diabetes.
I. Diabetic nephrpathy vs no renal disease
II. Diabetic nephropathy vs other renal diseases
* Investigation of biomarmers to differenciate I and II
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
To evaluate renal disease in patients with diabetes by renal biopsy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who go to our department from the time after approval of this study by the ethics committee of our hospital to March 31th, 2024.
2. Patients who agreee IC
3. Patients whose age is no less than 20 and no more than 80 at the time of IC.
Key exclusion criteria
1. Patients with diabetes due to other reasons except for type 1 and 2 diabetes, such as steroid-induced diabetes, Cushing syndrome, and genetic diabetes
2. Female in pregnancy or with possibility of pregnancy
3. Patients with high risk of renal biopsy
High risk is defined as any one of the following 6 criteria.
i. Platelet count < 100,000 (/ul) or definite disordered coagulation
ii. Usage of antiplatelet drug and anticoagulated drug which can not be stopped temporarily.
iii. Progressive anemia except for renal anemia
iv. Patients who can not keep a position in bed during renal biopsy.
v. Morphologic problems revealed by image information
Specifically, multiple cysts on the puncture line, renal cortex thickness < 10mm, and so on.
vi. Patients whom primary physician clinically defined as patients at high risk because of other reasons.
4. Patients under the emergency situations, such as life-threatening and infectious situation.
5. Baseline eGFR < 15ml/min/1.73m2
Target sample size
200
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
81-86-235-7235
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
81-86-235-7235
Homepage URL
kokims-frz@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Okayama university hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028235
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