UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015918 |
|---|---|
| Receipt number | R000018528 |
| Scientific Title | Association between serum bilirubin concentrations and diabetic nephropathy |
| Date of disclosure of the study information | 2014/12/11 |
| Last modified on | 2021/01/02 05:59:51 |
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Basic information
Public title
Association between serum bilirubin concentrations and diabetic nephropathy
Acronym
Association between serum bilirubin concentrations and diabetic nephropathy
Scientific Title
Association between serum bilirubin concentrations and diabetic nephropathy
Scientific Title:Acronym
Association between serum bilirubin concentrations and diabetic nephropathy
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, bilirubin has been paid attention as a strong endogenous antioxidant. The present study will be undertaken to reveal the association between bilirubin concentrations and diabetic nephropathy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes (N=439) who visited Kyushu University Hospital in April to June 2006 were recruited.
Key exclusion criteria
participants were enrolled after excluding hemolytic disease or alerted hepatic function or Gilbert syndrome or hyperfiltration.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toyoshi |
| Middle name | |
| Last name | Inoguchi |
Organization
Kyushu university
Division name
Innovation Center for Medical Redox Navigation
Zip code
8128582
Address
3-1-1 maidashi higashi-ku Fukuoka 812-8582, Japan
TEL
0926425284
toyoshi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyoshi |
| Middle name | |
| Last name | Inoguchi |
Organization
Kyushu university
Division name
Innovation Center for Medical Redox Navigation
Zip code
8128582
Address
3-1-1 maidashi higashi-ku Fukuoka 812-8582, Japan
TEL
0926425284
Homepage URL
toyoshi@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Ministry of Education, Scientific and Culture, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu university hospital
Address
3-1-1 maidashi higashi-ku Fukuoka 812-8582, Japan
Tel
+81 92 642 5774
ijkseimei@jimu.kyushu-u.ac.jp
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
| 2014 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
298
Results
unpublished
Results date posted
| 2021 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 63.5 years old. The mean body mass index (BMI) was 23.5 kg/m2. The median duration of follow-up was 9.0 years. During 10 years follow-up, 74 of 298 patients was classified into Progressive Renal Decline (PRD).
Participant flow
A total of 298 patients were enrolled for the data analysis. These participants represent approximately 68% of the whole cohort of the patients enrolled from April to June 2006 (n=429) after excluding the following; those who had incomplete laboratory data for analysis (n=4), patients with eGFR more than 120 mL/min/1.73m2 (n=16), those who suffered from hepatic diseases (n=4) and other kidney diseases (n=2) during the follow-up. In addition, patients with Gilbert syndrome were excluded in this study (n=14). We excluded the participants who were followed up for less than one year (n=91).
Adverse events
none
Outcome measures
Progressive Renal Decline (PRD).
Composite endpoint (ESKD or doubling of serum creatinine levels), or 30% reduction in eGFR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2006 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed the data of blood test which were collected at the out patient department.
Management information
Registered date
| 2014 | Year | 12 | Month | 11 | Day |
Last modified on
| 2021 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018528
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/10/20 | 211020 PRDカットオフ値リポジトリ用.xlsx |
