UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058857 |
|---|---|
| Receipt number | R000067311 |
| Scientific Title | Development of a Predictive Model for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) |
| Date of disclosure of the study information | 2025/08/21 |
| Last modified on | 2025/08/21 12:49:03 |
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Basic information
Public title
Development of a Predictive Model for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Acronym
Development of a Predictive Model for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Scientific Title
Development of a Predictive Model for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Scientific Title:Acronym
Development of a Predictive Model for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Nephrology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to identify clinical and biochemical predictors of acute kidney injury (AKI) and acute kidney disease (AKD) in patients undergoing transcatheter aortic valve implantation (TAVI), and to develop and validate a predictive model incorporating urinary biomarkers. The biomarkers to be analyzed include urinary L-FABP, NGAL, KIM-1, TIMP-2-IGFBP7, and clusterin, whose measurements were previously collected and analyzed in study No. 3049. These data will be further reanalyzed using nomograms, calibration plots, decision curve analysis (DCA), and bootstrap methods. We will observe the extent and dynamics of perioperative biomarker elevation, and investigate their association with AKD onset, chronic kidney disease (CKD) development and severity, and the rate of decline in estimated glomerular filtration rate (eGFR). Finally, we will evaluate whether AKI and AKD onset and renal prognosis, as well as survival prediction, can be accurately assessed using this model.
Basic objectives2
Others
Basic objectives -Others
The predictive value of clinical and biochemical factors and urinary biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ability to predict the onset of acute kidney injury (AKI) and acute kidney disease (AKD)
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo transcatheter valve implantation who provided informed consent prior to the procedure
Key exclusion criteria
Excluded dialysis patients and emergency cases
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St.Marianna university school of medicine
Division name
Anesthesiology
Zip code
213
Address
2-16-1 Sugao, Miyamae-Ku Kawasaki 216-8511
TEL
0449778111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St. marianna university school of medicine
Division name
Anesthesiology
Zip code
213
Address
2-16-1 Sugao, Miyamae-Ku Kawasaki
TEL
0453661111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university school of medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna university school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St marianna university school of medicine
Address
St. marianna university school of medicine
Tel
0453661111
y2obata@marianna-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
| 2025 | Year | 08 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067311
