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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017502
Receipt No. R000020284
Scientific Title Comparison of clinical trajectories between diabetic nephropathy and nephrosclerosis on the KDIGO guidelines heat map
Date of disclosure of the study information 2015/05/12
Last modified on 2017/01/18

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Basic information
Public title Comparison of clinical trajectories between diabetic nephropathy and nephrosclerosis on the KDIGO guidelines heat map
Acronym Comparison between diabetic nephropathy and nephrosclerosis
Scientific Title Comparison of clinical trajectories between diabetic nephropathy and nephrosclerosis on the KDIGO guidelines heat map
Scientific Title:Acronym Comparison between diabetic nephropathy and nephrosclerosis
Region
Japan

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

Objectives
Narrative objectives1 The aim of this analysis was to investigate the differences of clinical trajectories between diabetic nephropathy and nephrosclerosis using the Kidney Disease: Improving Global Outcomes (KDIGO) heat map and the clinical characteristics between the two diseases at the initiation of RRT.
Basic objectives2 Others
Basic objectives -Others To investigate the differences of clinical characteristics between diabetic nephropathy and nephrosclerosis at the initiation of RRT.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Initiation of RRT.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) More than 45 mL/min/1.73 m2 of eGFR at the first visit of our hospital, (2) follow up period in our hospital more than 24 months, and (3) received medical treatment by nephrologist for at least 12 months prior to RRT initiation.
Key exclusion criteria (1) age <20 years; (2) history of severe heart failure, angina, myocardial infarction, or stroke within 3 months prior to the initiation of the RRT; (3) initiated RRT due to acute kidney injury (AKI); (4) the primary cause of CKD other than diabetic nephropathy and nephrosclerosis (i.e. glomerulonephritis and cystic disease).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine Itabashi Hospital
Division name Nephrology, Hypertension and Endocrinology
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabshi-ku, Tokyo, Japan
TEL 03-3972-8111
Email mabe@med.nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension and Endocrinology
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
TEL 03-3972-8111
Homepage URL
Email mabe@med.nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 12 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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In the present study, conducted between January 2011 and December 2013, was performed to compare the clinical progression course of diabetic nephropathy and nephrosclerosis on the heat map according to the prognosis of CKD by GFR and albuminuria category in "KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease".Subjects who were initiated renal replacement therapy in our hospital between January 2011 and December 2013 were enrolled in the present study. The data were collected by the medical record.

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2017 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020284

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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