- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06939387
Drug-induced Kidney Injury Model
April 14, 2025 updated by: Zhejiang Provincial People's Hospital
Establishment, Evaluation and Treatment Strategy of Drug-induced Kidney Injury Model
To establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaolan Ye, Master
- Phone Number: +86-0571-85893117
- Email: yexl1120@126.com
Study Contact Backup
- Name: Ping Huang, doctor
- Phone Number: +86-0571-85893117
- Email: huangping1841@zjcc.org.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 311121
- Recruiting
- Zhejiang Provincial People's Hospital
-
Contact:
- Xiaolan Ye, Master
- Phone Number: +86-0571-85893117
- Email: yexl1120@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Drug-induced acute kidney injury
Description
Inclusion Criteria:
- Drug-induce acute kidney injury
Exclusion Criteria:
- 1.Dialysis patients; 2.No baseline creatinine; 3.Obstructive AKI; 4.Clinical data were incomplete.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Drug induced acute kidney injury
Patients with acute kidney injury caused by the use of nephrotoxic drugs
|
Observational study, no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Model performance metrics assessed by AUC-ROC, accuracy and F1-score using 10-fold cross-validation
Time Frame: through study completion, an average of 6 months
|
The prognosis of renal function was evaluated by measuring creatinine and proteinuria by laboratory tests.
Predict outcomes using machine learning methods.
And the prediction effect of the prediction model was evaluated by AUC-ROC, F1, accuracy and other indicators.
|
through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The rate at which creatinine falls
Time Frame: 7 days, 1 month, 3 months after treatment
|
7 days, 1 month, 3 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2025
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
April 14, 2025
First Posted (Actual)
April 22, 2025
Study Record Updates
Last Update Posted (Actual)
April 22, 2025
Last Update Submitted That Met QC Criteria
April 14, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KT2024116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We will publish relevant research papers, patient data is not appropriate for public disclosure
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.