UMIN-CTR Clinical Trial

Basic information
Public title	A case-control study on the influence of glycolipid GM3 in glomerular disease
Acronym	GM3 in glomerular disease study
Scientific Title	A case-control study on the influence of glycolipid GM3 in glomerular disease
Scientific Title:Acronym	GM3 in glomerular disease study
Region	Japan

Condition
Condition	glomerular disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the association between glycolipid GM3 expression and glomerular disease.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	proteinuria, renal function after 2 years of renal biopsy
Key secondary outcomes

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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Diseased: Patients diagnosed with renal biopsyin in Kitasato university hospital, division of nephrology(2010/1/1-2015/12/31) a) MCNS, b) FSGS, c) IgA-nephritis, d) Membrane nephritis, e) DM-N 2) control Nephrectomy patients who assent in Kitasato University Hospital, Division of Urology (2018/4/1-2020/12/31). age: 20-75 ages
Key exclusion criteria	Participation refusal from principal or agent
Target sample size	230

Research contact person
Name of lead principal investigator	1st name SHOKICHI Middle name Last name NAITO
Organization	KITASATO UNIVERSITY HOSPITAL
Division name	DIVISION OF NEPHROLOGY
Zip code	252-0375
Address	1-15-1 Kitasato, Minami, Sagamihara, 252-0374, Japan
TEL	042-778-8111
Email	snaito@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name SHOKICHI Middle name Last name NAITO
Organization	KITASATO UNIVERSITY HOSPITAL
Division name	DIVISION OF NEPHROLOGY
Zip code	252-0375
Address	1-15-1 Kitasato, Minami, Sagamihara, 252-0374, Japan
TEL	042-778-8111
Homepage URL
Email	snaito@med.kitasato-u.ac.jp

Sponsor
Institute	KITASATO UNIVERSITY HOSPITAL
Institute
Department

Funding Source
Organization	Kitasato University, School Of Medicene
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University Medical Ethics Organization (KMEO)
Address	1-15-1 Kitasato, Minami, Sagamihara, 252-0374, Japan
Tel	042-778-8273
Email	rinrib@med.kitasato-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 10 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	228
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	Completed
Date of protocol fixation	2018 Year 02 Month 07 Day
Date of IRB	2018 Year 02 Month 07 Day
Anticipated trial start date	2018 Year 04 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Case-control study

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035973