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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011448
Receipt No. R000012972
Scientific Title Clinical implications of linear immunofluorescent staining for immunoglobulin G in patients with diabetic nephropathy
Date of disclosure of the study information 2013/08/12
Last modified on 2015/06/10

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Basic information
Public title Clinical implications of linear immunofluorescent staining for immunoglobulin G in patients with diabetic nephropathy
Acronym Linear IgG staining in diabetic nephropathy
Scientific Title Clinical implications of linear immunofluorescent staining for immunoglobulin G in patients with diabetic nephropathy
Scientific Title:Acronym Linear IgG staining in diabetic nephropathy
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between linear IgG staining of diabetic nephropathy and the clinical outcome
Basic objectives2 Others
Basic objectives -Others Clinical significance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Commencement of dialysis due to ESRD
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diabetes mellitus who underwent renal biopsy at our hospital and were confirmed to have diabetic nephropathy according to Tervaert's classification(J Am Soc Nephrol. 2010;21(4):556-63)
Key exclusion criteria Kidney transplantation, coexistence of other renal diseases except for nephrosclerosis, obtaining fewer than 5 glomeruli by renal biopsy, glomerular class IV, and no glomerulus or global screlosis in the immunofluorescent tissue for IgG
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenmei Takaichi
Organization Toranomon Hospital
Division name Nephrology Center
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo, 105-0001, Japan
TEL 03-3588-1111
Email takaichi@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name KokiMise
Organization Toranomon Hospital Kajigaya
Division name Nephrology Center
Zip code
Address 1-3-1, Kajigaya, Takatu-ku, Kawasaki-shi, Kanagawa-ken, 213-0015, Japan
TEL 044-877-5111
Homepage URL
Email kokims-frz@umin.ac.jp

Sponsor
Institute Nephrology Center, Toranomon Hospital
Institute
Department

Funding Source
Organization Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 虎の門病院(東京)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0168822714004513
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 Completed
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients who were confirmed to have pure diabetic nephropathy according to the classification of Tervaert et al. were enrolled in this study. Immunofluorescent IgG staining was classified into three categories (0=none, 1=weakly positive, 2= positive) according to its intensity. Cox proportional hazards regression analysis was used to calculate the hazard ratio (HR) and 95% confidence interval (CI) for death-censored renal death, with each regression analysis examining two levels of multivariate adjustment. Renal death was defined as commencement of dialysis due to end-stage renal disease.

Management information
Registered date
2013 Year 08 Month 10 Day
Last modified on
2015 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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