UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022542 |
|---|---|
| Receipt number | R000025972 |
| Scientific Title | Paratubular basement membrane insudative lesions predict renal prognosis in patients with type 2 diabetes and biopsy-proven diabetic nephropathy |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2016/05/30 22:03:44 |
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Basic information
Public title
Paratubular basement membrane insudative lesions predict renal prognosis in patients with type 2 diabetes and biopsy-proven diabetic nephropathy
Acronym
Paratubular basement membrane insudative lesions
Scientific Title
Paratubular basement membrane insudative lesions predict renal prognosis in patients with type 2 diabetes and biopsy-proven diabetic nephropathy
Scientific Title:Acronym
Paratubular basement membrane insudative lesions
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 paratubular basement membrane insudative lesions and renal prognosis in patients with biopsy-proven diabetic nephropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
40% eGFR decline from baseline
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 type 2 diabetes who underwent renal biopsy at Toranomon hospital (Toranomon Main Hospitan and Toranomon Hospital Kajigaya) from January 1998 to June 2011 and were confirmed to have DN alone.
Key exclusion criteria
Exclusion criterion was eGFR < 10ml/min/1.73m2 at the time of renal biopsy.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Ubara |
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
ubara@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koki Mise |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama-ken, 700-8558, Japan
TEL
086-235-7235
Homepage URL
kokims-frz@umin.ac.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Agency for Medical Research and Development. Okinaka Memorial Institute for Medical Research. Japan Association for Diabetes Education and Care. The Kidney Foundation, Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
虎の門病院分院(神奈川県)、虎の門病院(東京)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among most patients who were eligible for this study, various severity of insudation between tubular epithelial cells and the tubular basement membrane (TBM) was observed in cortex and medulla. We named the insudative lesion as paratubular basement membrane isudative lesions (PTBMIL). PTBMIL in cortex and medulla were classified into four grades according to the severiry. Finally, patients were classified into three groups according to the total of cortical and medullary PTBMIL grades.
The Cox proportional hazard model was used to calculate the hazard ratio (HR) and 95% confidence interval (CI) for the death-censored endpoint. We investigated the hazard ratio of PTBMIL groups for the outcome of interest in univariate and multivariate Cox proportional models.
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2016 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025972
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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