A Clinical Diagnostic System for Intrinsic Acute Kidney Disease

Completed

• Conditions: Acute Kidney Disease
• Interventions: Diagnostic Test: Clinical model; Diagnostic Test: Urinary biomarkers

• Registration Number: NCT06606522

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.

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 Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-06-30
• Status Verified: 2024-08
• Study Completion: 2024-09-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1360

Inclusion Criteria

• Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Dec. 31, 2024.

Exclusion Criteria

• Patients were excluede if they

  1. underwent a biopsy to evaluate renal allograft rejection;
  2. had a history of hematopoietic stem cell transplantation;
  3. were diagnosed with hematological malignancy or end-stage tumor with kidney metastasis;
  4. were tested antineutrophil cytoplasmic autoantibody (ANCA) or double-strand DNA (dsDNA) or anti-glomerular basement membrane (GBM) antibody positive before biopsy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Derivation cohort	Clinical model	Patients from Peking University First Hospital
Derivation cohort	Urinary biomarkers	Patients from Peking University First Hospital
External Validation Cohort	Clinical model	Patients from other four centers
External Validation Cohort	Urinary biomarkers	Patients from other four centers

Primary Outcome Measures

Name	Time	Method
Histological diagnosis of AKD	within a week after biopsy	Number of definite biopsy-proven histological diagnosis of AKD

Trial Locations

Locations (1)

Dongzhimen Hospital of Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China