A Clinical Diagnostic System for Intrinsic Acute Kidney Disease

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.

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Key information

Conditions

Acute Kidney Disease

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Miyun District Hospital, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients were excluede if they

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

Treatment and study plan

Clinical model

Diagnostic Test

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

Urinary biomarkers

Diagnostic Test

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

Primary outcomes

Histological diagnosis of AKD

Time frame: within a week after biopsy

Number of definite biopsy-proven histological diagnosis of AKD

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

Affiliated Hospital of Hebei University
Beijing Miyun Hospital
Dongzhimen Hospital, Beijing
Taiyuan Central Hospital of Shanxi Medical University

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 23, 2024
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed