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Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy Study

Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy Study - NExT-DN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024530
Enrollment
200
Registered
2017-04-01
Start date
2017-03-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Diabetic nephropathy

Interventions

To evaluate renal disease in patients with diabetes by renal biopsy

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
eGFR 30-40% decline from baseline

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKoki Mise

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

kokims-frz@okayama-u.ac.jp81-86-235-7235

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026