UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020460
Receipt No. R000022903
Scientific Title Circulating KIM-1, TNF receptors 1/2, and other markers in early diabetic nephropathy in Japanese with type 2 diabetes.
Date of disclosure of the study information 2016/01/08
Last modified on 2018/01/11

* 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 Circulating KIM-1, TNF receptors 1/2, and other markers in early diabetic nephropathy in Japanese with type 2 diabetes.
Acronym KIM-1, sTNFR1/2, and nephropathy markers in type 2 diabetes
Scientific Title Circulating KIM-1, TNF receptors 1/2, and other markers in early diabetic nephropathy in Japanese with type 2 diabetes.
Scientific Title:Acronym KIM-1, sTNFR1/2, and nephropathy markers in type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the role of markers of diabetic nephropathy in Japanese with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Besides standard blood chemistry and urinary albumin excretion, serum KIM-1 (ELISA), sTNFR1/2 (ELISA), NGAL (ELISA), urinary MCP-1 (ELISA), and cystatin C (ELISA) are measured at enrollment.
Key secondary outcomes The association of the rate of decline of glomerular filtration rate with measured nephropathy markers is analyzed in enrolled subjects.

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes who fulfilled the following criteria.

1) Aged 20 and over
2) Patients whose baseline eGFR were
>=30ml/min/1.73m^2
3) Having provided voluntary written consent for participation in this study.

Key exclusion criteria Patients corresponding to any of the following are inapplicable
1)Patients with severe complications( liver disease, mental disorder, cancer)
2)Patients with severe ketosis or diabetic coma.
3)Patients with severe infections, perioperative status, or severe trauma
4) Patients whose baseline eGFR were <29 ml/min/1.73m^2
5) Patients with kidney disease other than diabetic nephropathy.(Specifically, patients with occult blood positive)
Patients with renal transplantations, or using drugs with nephrotoxic.
6)Pregnancy or lactation in women
7)Inadequacy of usingig this therapy

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2639
Email terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Konishi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2639
Homepage URL
Email t146035b@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization None
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(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 08 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study
Recruitment of Subject:
Patients with type 2 diabetes in our hospital and Yokohama Minami Kyousai Hospital,Yokohama Chuo Hospital,
Kanazawa Medical Clinic and
Nakajima Naika Clinic who fulfilled the inclusion/exclusion criteria.
Recruitment period:from January 2016 to August 2018
Evaluation of correlation between the novel biomarkers, such as KIM-1,solublebTNFR1,soluble TNFR2,NGAL and MCP-1, and the predictors for development of diabetic nephropathy in patients with type 2 diabetes mellitus.

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2018 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.