UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017502 |
|---|---|
| Receipt number | 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 14:20:30 |
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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
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
mabe@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020284
