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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046398

Enrollment

100

Registered

2022-01-01

Start date

2021-12-16

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

Diabetic kidney disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Correlation of novel biomerkers and pathophysiological targets in renal tissue, urine, and blood with pathological finding of DKD	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

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.jp086-235-7235

Outcome results