Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606522
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
A Clinical Diagnostic System for Intrinsic Acute Kidney Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Diagnostic System of Clincial Model and Urinary Biomarkers for Intrinsic Acute Kidney Disease
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational cross-sectional study is to develop a clinical diagnostic system for intrinsic acute kidney disease AKD to help clincians make non-invasive diagnosis when a kidney biopsy is not available The main questions it aims to answer are
1 Can a clinical model comprised of common clinical indexes help diagnose AKD
2 Can a combinition of several urinary biomarkers help diagnose AKD The study will be conducted in retrospective cohorts of patients with AKD undergoing kidney biopsy The gold standard of the study is histological diagnosis of AKD The model will be developed in a derivation cohort from one center and will be further externally validated in a multicent cohort The urinary biomarkers will only be tested in the derivation cohort
1 Can a clinical model comprised of common clinical indexes help diagnose AKD
2 Can a combinition of several urinary biomarkers help diagnose AKD The study will be conducted in retrospective cohorts of patients with AKD undergoing kidney biopsy The gold standard of the study is histological diagnosis of AKD The model will be developed in a derivation cohort from one center and will be further externally validated in a multicent cohort The urinary biomarkers will only be tested in the derivation cohort
Detailed Description:
Acute kidney disease is a frequent syndrome characterized by a sudden loss of kidney function AKD caused by intrinsic kidney diseases are usually more severe than other causes The treatment of intrinsic AKD mostly depends on a definite pathological diagnosis requiring invasive kidney biopsy which is not available in all AKD cases The goal of this study is to develop a clinical diagnostic system comprised of clinical model and urinary biomarkers for intrinsic AKD to help clincians make non-invasive diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None