UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021770
Receipt number R000025105
Scientific Title Analysis of renal expression of LRG-1 (leucine-rich alpha-2-glycoprotein 1) in pathophysiology of kidney disease
Date of disclosure of the study information 2016/04/05
Last modified on 2016/04/04 16:53:36

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Basic information

Public title

Analysis of renal expression of LRG-1 (leucine-rich alpha-2-glycoprotein 1) in pathophysiology of kidney disease

Acronym

Analysis of LRG1 expression in kidney disease

Scientific Title

Analysis of renal expression of LRG-1 (leucine-rich alpha-2-glycoprotein 1) in pathophysiology of kidney disease

Scientific Title:Acronym

Analysis of LRG1 expression in kidney disease

Region

Japan


Condition

Condition

Kidney disease, hypertension, cardiovascular disease

Classification by specialty

Medicine in general Cardiology Nephrology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

This study will examine the distribution of LRG1 in the normal kidney tissues of dissected kidney by nephrectomy and in the renal biopsy specimens derived from diseased kidney, and investigate a putative role of LRG1 in renal physiology and pathophysiology.

Basic objectives2

Others

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The distribution of LRG1 in the normal kidney tissues of dissected kidney by nephrectomy and in the renal biopsy specimens derived from diseased kidney, and its relationship with parameters of renal function, CKD CGA classification, diabetic nephropathy classification, and renal events (serum creatinine doubling, dialysis induction and total mortality.

Key secondary outcomes

Parameters of renal and cardiovascular function, glucose, lipid and electrolyte metabolism, renin-angiotensin system, urinary fibrotic and inflammatory factors, and ambulatory blood pressure monitoring.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who are going to undergo renal biopsy for the scrutiny of kidney disease, and those who already underwent renal biopsy for the same purpose.
2. Patients who already underwent nephrectomy and whose resected renal tissues are preserved in the tissue repository.

Key exclusion criteria

Patients who are considered inappropriate for inclusion in the study.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichi TAMURA

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2800

Email

tamukou@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dr. Sona Haku

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

Homepage URL


Email

t106048f@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 05 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

Date of protocol fixation

2016 Year 04 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 05 Day

Last follow-up date

2021 Year 02 Month 28 Day

Date of closure to data entry

2021 Year 02 Month 28 Day

Date trial data considered complete

2021 Year 02 Month 28 Day

Date analysis concluded

2021 Year 02 Month 28 Day


Other

Other related information

1. Aim of the study
 This study will examine the distribution of LRG1 in the normal kidney tissues of dissected kidney by nephrectomy and in the renal biopsy specimens derived from diseased kidney, and investigate a putative role of LRG1 in renal physiology and pathophysiology.

2. Study patients
(1) Inclusion criteria
1) Patients who are going to undergo renal biopsy for the scrutiny of kidney disease, and those who already underwent renal biopsy for the same purpose.
2) Patients who already underwent nephrectomy and whose resected renal tissues are preserved in the tissue repository.
(2) Exclusion criteria
1) Patients who are considered inappropriate for inclusion in the study.

3. Study design, number of participants and study duration
(1) Study design
The study includes prospective and retrospective cohort analysis.
(2) Number of participants
N=120.
(3) Study duration
From April 5, 2016 to February 28, 2021.

4. Outcomes
(1) Primary outcomes
The distribution of LRG1 in the normal kidney tissues of dissected kidney by nephrectomy and in the renal biopsy specimens derived from diseased kidney, and its relationship with parameters of renal function, CKD CGA classification, diabetic nephropathy classification, and renal events (serum creatinine doubling, dialysis induction and total mortality).
(2) Secondary outcomes
Parameters of renal and cardiovascular function, glucose, lipid and electrolyte metabolism, activity of renin-angiotensin system, fibrosis and inflammation, and ambulatory blood pressure monitoring.


Management information

Registered date

2016 Year 04 Month 04 Day

Last modified on

2016 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025105


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name