UMIN-ICDS Clinical Trial

Public title

A longitudinal study of clinicopathological characteristics, blood biomarkers, and renal outcomes in patients undergoing kidney biopsy

Acronym

A longitudinal study of clinicopathological characteristics, blood biomarkers, and renal outcomes in patients undergoing kidney biopsy

Scientific Title

A longitudinal study of clinicopathological characteristics, blood biomarkers, and renal outcomes in patients undergoing kidney biopsy

Scientific Title:Acronym

A longitudinal study of clinicopathological characteristics, blood biomarkers, and renal outcomes in patients undergoing kidney biopsy

Region

Japan

Condition

Kidney diseases requiring renal biopsy

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to integrate clinical data obtained at the time of renal biopsy and during the periods before and after biopsy, renal histopathological findings, treatment information, and long-term laboratory data and clinical outcomes in patients who underwent renal biopsy, with the following objectives:
1. To investigate the associations between clinical phenotypes and renal histopathological findings.
2. To evaluate the associations of clinical phenotypes, histopathological findings, and treatment choices with subsequent clinical outcomes, including changes in proteinuria, hematuria, and renal function, remission, relapse, initiation of kidney replacement therapy, and mortality.
3. To evaluate real-world treatment responses to different therapeutic approaches and identify patient characteristics and histopathological findings associated with heterogeneity in treatment responses.
4. To measure circulating proteins in research serum and plasma samples collected and stored at the time of renal biopsy under broad informed consent, focusing on proteins suggested by previous studies or exploratory analyses to be associated with the pathophysiology of kidney diseases, renal histopathological findings, clinical phenotypes, treatment responses, or renal prognosis, and to investigate these associations.
5. To integrate clinical, histopathological, and circulating protein data to identify disease subtypes and to explore the development and internal validation of predictive models for diagnosis, prognosis, and treatment response.For circulating protein analyses, comparisons with healthy controls will be performed as appropriate.

Basic objectives2

Others

Basic objectives -Others

Exploratory investigation of disease subtypes and diagnostic, prognostic, and treatment response predictors through integrated analysis of clinical data, renal histopathological findings, treatment information, long-term clinical outcomes, and circulating protein profiles in patients undergoing kidney biopsy.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of change in estimated glomerular filtration rate (eGFR) over time following kidney biopsy (eGFR slope, mL/min/1.73 m2/year). The eGFR slope will be estimated using individual-level regression or longitudinal models based on multiple available eGFR measurements.

Key secondary outcomes

1. Longitudinal changes, time-averaged values, absolute and relative changes in urinary protein-to-creatinine ratio (UPCR), urinary albumin-to-creatinine ratio (UACR), and 24-hour urinary protein excretion; proteinuria remission and relapse.
2. Longitudinal changes in urine dipstick hematuria, urinary sediment red blood cell counts, and gross hematuria; hematuria remission.
3. Longitudinal changes in serum creatinine and estimated glomerular filtration rate (eGFR); 30%, 40%, and 50% declines in eGFR; doubling of serum creatinine; sustained severe reduction in kidney function; end-stage kidney disease (ESKD); and initiation of kidney replacement therapy (KRT), including dialysis and kidney transplantation.
4. Disease-specific complete remission, partial remission, treatment resistance, relapse, and disease flare, and time to each event.
5. Acute kidney injury, hospitalization, cardiovascular events, infectious events, malignancy, all-cause mortality, and cause-specific mortality when the cause of death is available.
6. Associations of treatment modalities and therapeutic strategies with the above outcomes, heterogeneity of treatment effects, and factors associated with treatment selection.
7. Associations of clinical phenotypes, histopathological findings, and circulating protein concentrations or relative expression levels with diagnostic classification, histopathological activity and chronicity, treatment response, and long-term outcomes.
8. Disease subtypes, risk stratification indices, and predictive models defined by integrating clinical, histopathological, and circulating protein data; model discrimination, calibration, and internal validation results.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who underwent kidney biopsy at Nihon University Itabashi Hospital between April 1, 2009, and June 30, 2031.
2. Healthy individuals who underwent health checkups at Hatogaya Hospital between July 1, 2019, and July 1, 2030, who provided informed consent for research use and secondary use of their data and samples in previous studies, and whose stored serum or plasma samples are available for use in the present study.

Key exclusion criteria

1. Persons who express their unwillingness to participate in this study.
2. Persons deemed by the principal investigator to be unsuitable for inclusion in this study for any reason.

Target sample size

950

Name of lead principal investigator

1st name	Hiroki
Middle name
Last name	Kobayashi

Organization

Nihon University School of Medicine

Division name

Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine

Zip code

173-8610

Address

30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo

TEL

+81-3-3972-8111

Email

kobayashi.hiroki@nihon-u.ac.jp

Name of contact person

1st name	Hiroki
Middle name
Last name	Kobayashi

Organization

Nihon University School of Medicine

Division name

Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine

Zip code

173-8610

Address

30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo

TEL

+81-3-3972-8111

Homepage URL

Email

kobayashi.hiroki@nihon-u.ac.jp

Institute

Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan

Institute

Department

Personal name

Organization

Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Hatogaya Hospital

Name of secondary funder(s)

Organization

Nihon university Itabashi hospital clinical reseach center

Address

30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo

Tel

+81-3-3972-8111

Email

med.rinsyokenkyu@nihon-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

10

Month

23

Day

Date of IRB

2026

Year

10

Month

14

Day

Anticipated trial start date

2026

Year

10

Month

29

Day

Last follow-up date

2031

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Rate of change in estimated glomerular filtration rate (eGFR) over time following kidney biopsy (eGFR slope, mL/min/1.73 m2/year). The eGFR slope will be estimated using individual-level regression or longitudinal models based on multiple available eGFR measurements.

Longitudinal changes, time-averaged values, absolute and relative changes in urinary protein-to-creatinine ratio (UPCR), urinary albumin-to-creatinine ratio (UACR), and 24-hour urinary protein excretion; proteinuria remission and relapse.

Longitudinal changes in urine dipstick hematuria, urinary sediment red blood cell counts, and gross hematuria; hematuria remission.

Longitudinal changes in serum creatinine and estimated glomerular filtration rate (eGFR); 30%, 40%, and 50% declines in eGFR; doubling of serum creatinine; sustained severe reduction in kidney function; end-stage kidney disease (ESKD); and initiation of kidney replacement therapy (KRT), including dialysis and kidney transplantation.

Disease-specific complete remission, partial remission, treatment resistance, relapse, and disease flare, and time to each event.

Acute kidney injury, hospitalization, cardiovascular events, infectious events, malignancy, all-cause mortality, and cause-specific mortality when the cause of death is available.

Associations of treatment modalities and therapeutic strategies with the above outcomes, heterogeneity of treatment effects, and factors associated with treatment selection.

Associations of clinical phenotypes, histopathological findings, and circulating protein concentrations or relative expression levels with diagnostic classification, histopathological activity and chronicity, treatment response, and long-term outcomes.

Disease subtypes, risk stratification indices, and predictive models defined by integrating clinical, histopathological, and circulating protein data; model discrimination, calibration, and internal validation results.

Registered date

2026

Year

10

Month

29

Day

Last modified on

2026

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072541