UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051147 |
|---|---|
| Receipt number | R000058328 |
| Scientific Title | Association between dipeptidyl peptidase-4 inhibitor and acute kidney injury |
| Date of disclosure of the study information | 2023/05/24 |
| Last modified on | 2024/05/22 12:05:49 |
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Basic information
Public title
Association between dipeptidyl peptidase-4 inhibitor and acute kidney injury
Acronym
Dipeptidyl peptidase-4 inhibitor and kidney injury
Scientific Title
Association between dipeptidyl peptidase-4 inhibitor and acute kidney injury
Scientific Title:Acronym
Dipeptidyl peptidase-4 inhibitor and kidney injury
Region
| Japan |
Condition
Condition
Adult with diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Some DPP-4 inhibitors have been suggested to increase the risk of developing cardiovascular events. Cardiovascular disease is known to be associated with an increased risk of kidney injury, and therefore some DPP4 inhibitors may increase the risk of acute kidney injury. However, the association between DPP4 inhibitors and kidney events has not been evaluated. The purpose of this study was to examine the relationship between DPP4 inhibitors and the risk of acute kidney injury by meta-analysis of randomized controlled trials.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute kidney injury
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Adult with diabetes mellitus
Key exclusion criteria
Children, transplantation, gestational diabetes, use of DPP4 inhibitors for non-diabetics mellitus, and no outcome assessment for acute kidney injury.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Mitsuboshi |
Organization
Kaetsu Hospital
Division name
Department of pharmacy
Zip code
956-0814
Address
1459-1, Higashikanazawa, Niigata-City, Niigata, Japan
TEL
0250-22-4711
ccrtyo34057@gmail.com
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Mitsuboshi |
Organization
Kaetsu Hospital
Division name
Department of pharmacy
Zip code
956-0814
Address
1459-1, Higashikanazawa, Niigata-City, Niigata, Japan
TEL
0250-22-4711
Homepage URL
ccrtyo34057@gmail.com
Sponsor or person
Institute
Kaetsu Hospital
Institute
Department
Personal name
mitsuboshi satoru
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kaetsu Hospital
Address
1459-1, Higashikanazawa, Niigata-City, Niigata, Japan
Tel
0250-22-4711
ccrtyo34057@gmail.com
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
| 2023 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/bcpt.14014
Number of participants that the trial has enrolled
56117
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
| 2023 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 10 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058328
