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A Clinical Diagnostic System for Intrinsic Acute Kidney Disease

A Diagnostic System of Clincial Model and Urinary Biomarkers for Intrinsic Acute Kidney Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06606522
Enrollment
1360
Registered
2024-09-23
Start date
2024-06-01
Completion date
2024-09-09
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Disease

Keywords

acute kidney disease, kidney biopsy, diagnostic model, urinary biomarkers

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.

Interventions

DIAGNOSTIC_TESTClinical model

Clinical model: a clinical model based on basic demorgraphic information and commonly executed laboratory tests to differentiate different pathological types of intrinsic AKD.

DIAGNOSTIC_TESTUrinary biomarkers

Urinary biomarkers: biomarkers help differentiate different pathological types of intrinsic AKD.

Sponsors

Affiliated Hospital of Hebei University
CollaboratorOTHER
Beijing Miyun Hospital
CollaboratorUNKNOWN
Dongzhimen Hospital, Beijing
CollaboratorOTHER
Taiyuan Central Hospital of Shanxi Medical University
CollaboratorOTHER
Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Histological diagnosis of AKDwithin a week after biopsyNumber of definite biopsy-proven histological diagnosis of AKD

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026