UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013409 |
|---|---|
| Receipt number | R000015647 |
| Scientific Title | Clinical and pathological predictors of estimated GFR decline in patients with type 2 diabetes and macroalbuminuric diabetic nephropathy |
| Date of disclosure of the study information | 2014/03/31 |
| Last modified on | 2015/06/10 23:43:36 |
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Basic information
Public title
Clinical and pathological predictors of estimated GFR decline in patients with type 2 diabetes and macroalbuminuric diabetic nephropathy
Acronym
eGFR decline in biopsy-proven diabetic nephropathy
Scientific Title
Clinical and pathological predictors of estimated GFR decline in patients with type 2 diabetes and macroalbuminuric diabetic nephropathy
Scientific Title:Acronym
eGFR decline in biopsy-proven 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 relationships of the eGFR decline with clinical and pathological variables in patients with type 2 diabetes and macroalbuminuric biopsy-proven diabetic nephropathy
Basic objectives2
Others
Basic objectives -Others
To compare the utility as a predictor of rapid eGFR decliners between clinical and pathological variables.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual eGFR decline
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
Transplanted kidney
Coexistence of other renal diseases except for nephrosclerosis
Type I diabetes
normoalbuminuria or microalbuminuria
eGFR <15 mL/min/1.73 m2 at baseline
follow-up for less than 12 months except for commencement of dialysis within 12 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Ubara |
Organization
Toranomon Hospital
Division name
Nephrology Center
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo, 105-0001, Japan
TEL
03-3588-1111
ubara@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koki Mise |
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
kokims-frz@umin.ac.jp
Sponsor or person
Institute
Nephrology Center, Toranomon Hospital
Institute
Department
Personal name
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
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
| 2014 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25533683
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 | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Serum creatinine was measured more than once a year and at final follow-up in each patient. The GFR was estimated by using the Japanese coefficient-modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
For each patient, a linear regression model of time versus eGFR was created, and the slope of the regression line was used to estimate the changes of eGFR over time. The eGFR slope was also expressed as an annual percentage (the slope divided by the baseline eGFR).
Multivariate linear regression analyses were employed to explore the association of annual eGFR decline with baseline clinical and histopathological covariates. In each model, the dependent variable was annual eGFR decline (% per year), while the age, sex, BMI, diabetic retinopathy, and clinical and histopatological variables at the time of renal biopsy were included as covariates.
Management information
Registered date
| 2014 | Year | 03 | Month | 13 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015647
