UMIN-CTR Clinical Trial

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
Last 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
Email	junwada@okayama-u.ac.jp

Public contact
1st 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
Email	kokims-frz@okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028235