UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021770
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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
URL(English) https://upload.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


Contact us.