Drug-induced Kidney Injury Model | NCT06939387

Studies
Drug-induced Kidney Injury Model

NCT06939387

Sponsor

Zhejiang Provincial People's Hospital

Status

Recruiting

Last Update Posted

Apr 22, 2025Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Observational study, no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2025Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Mar 10, 2025

First Submission Date that Met QC Criteria

Apr 14, 2025

First Posted Date

Apr 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2025

Last Update Posted Date

Apr 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Zhejiang Provincial People's HospitalOTHER

Collaborators

Name	Class
Taizhou Enze Medical Center Group	OTHER
Hangzhou Linping District first People's Hospital	UNKNOWN
Aksu district first People's Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug induced acute kidney injury		Patients with acute kidney injury caused by the use of nephrotoxic drugs	Other: Observational study, no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational study, no intervention	Other	Observational study, no intervention	Drug induced acute kidney injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	through study completion, an average of 6 months

Secondary Outcomes

Measure	Description	Time Frame
The rate at which creatinine falls		7 days, 1 month, 3 months after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Drug-induce acute kidney injury

Exclusion Criteria:

1.Dialysis patients; 2.No baseline creatinine; 3.Obstructive AKI; 4.Clinical data were incomplete.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Drug-induced acute kidney injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xiaolan Ye, master	Contact	+86-0571-85893117		yexl1120@126.com
Ping Huang, doctor	Contact	+86-0571-85893117		huangping1841@zjcc.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang Provincial People's Hospital	Recruiting	Hangzhou	Zhejiang	311121	China

IPD Sharing Statement Module

Plan to Share IPD

Description

We will publish relevant research papers, patient data is not appropriate for public disclosure

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided