Acute Kidney InjuryNCT06939387
Drug-induced Kidney Injury Model
An observational study of Acute Kidney Injury, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
To establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 30 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Drug-induced acute kidney injury
Who may be able to join
- Drug-induce acute kidney injury
Who cannot join
- 1.Dialysis patients; 2.No baseline creatinine; 3.Obstructive AKI; 4.Clinical data were incomplete.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 311121
Xiaolan Ye, Master, +86-0571-85893117, yexl1120@126.com
About this study
Official title: 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
- Conditions
- Acute Kidney Injury
- Being tested
- Observational study, no intervention
- Keywords
- acute kidney injury, drug
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Drug induced acute kidney injury | Patients with acute kidney injury caused by the use of nephrotoxic drugs Receives: Other: Observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model performance metrics assessed by AUC-ROC, accuracy and F1-score using 10-fold cross-validation
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.
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
The rate at which creatinine falls
Measured: 7 days, 1 month, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start10 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, Hangzhou Linping District first People's Hospital, Aksu district first People's Hospital, Ningbo Yinzhou District Second Hospital, Wucheng District First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939387
- Sponsor's protocol ID
- KT2024116
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will publish relevant research papers, patient data is not appropriate for public disclosure
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment, Evaluation and Treatment Strategy of Drug-induced Kidney Injury Model
- ClinicalTrials.gov ID
- NCT06939387
- Acronym / sponsor ID
- KT2024116
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, drug
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, Hangzhou Linping District first People's Hospital, Aksu district first People's Hospital, Ningbo Yinzhou District Second Hospital, Wucheng District First People's Hospital
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug induced acute kidney injury | – | Other: Observational study, no interventionPatients with acute kidney injury caused by the use of nephrotoxic drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Drug-induced acute kidney injury
Key inclusion criteria (1 listed)
- Drug-induce acute kidney injury
Key exclusion criteria (1 listed)
- 1.Dialysis patients; 2.No baseline creatinine; 3.Obstructive AKI; 4.Clinical data were incomplete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no interventionObservational study, no intervention | Other | Drug induced acute kidney injury |
Primary outcome
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.
1 secondary outcome
The rate at which creatinine falls
Time frame: 7 days, 1 month, 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No. We will publish relevant research papers, patient data is not appropriate for public disclosure
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaolan Ye, master (+86-0571-85893117, yexl1120@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.