UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058010 |
|---|---|
| Receipt number | R000066311 |
| Scientific Title | Predictive Modeling of Acute Kidney Disease (AKD) Development in Patients Undergoing TAVI |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/29 13:50:52 |
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Basic information
Public title
Predictive Modeling of Acute Kidney Disease (AKD) Development in Patients Undergoing TAVI
Acronym
Predictive Modeling of Acute Kidney Disease (AKD) Development in Patients Undergoing TAVI
Scientific Title
Predictive Modeling of Acute Kidney Disease (AKD) Development in Patients Undergoing TAVI
Scientific Title:Acronym
Predictive Modeling of Acute Kidney Disease (AKD) Development in Patients Undergoing TAVI
Region
| Japan |
Condition
Condition
Aortic stenosis, chronic kidney disease, acute kidney disease, acute kidney injury
Classification by specialty
| Medicine in general | Nephrology | Anesthesiology |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify clinical and biochemical predictors of AKD development in patients undergoing TAVI and to develop and evaluate a predictive model combining urinary biomarkers.
The biomarkers will include urinary L-FABP, urinary NGAL, urinary KIM-1, urinary TIMP2/IGFBP7, urinary clusterin, urinary TFF4, and urinary Netrin. The extent and trends of perioperative biomarker elevations will be observed and evaluated for their usefulness in predicting AKD onset and severity of CKD, eGFR reduction rate, renal prognosis and life expectancy.
Basic objectives2
Others
Basic objectives -Others
To identify clinical and biochemical predictors of AKD development in patients undergoing TAVI and to develop and evaluate a predictive model combining urinary biomarkers.
The biomarkers will include urinary L-FABP, urinary NGAL, urinary KIM-1, urinary TIMP2/IGFBP7, urinary clusterin, urinary TFF4, and urinary Netrin. The extent and trends of perioperative biomarker elevations will be observed and evaluated for their usefulness in predicting AKD onset and severity of CKD, eGFR reduction rate, renal prognosis and life expectancy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of acute kidney disease, progression of chronic kidney disease, death, introduction of dialysis
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 undergoing TAVI
Key exclusion criteria
Emergency, Dialysis
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St. Marianna Medical University
Division name
Anesthesiology
Zip code
2168511
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
216-8511
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
0449778111
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 | 05 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2035 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066311
