Clinical trial NCT06606522: A Clinical Diagnostic System for Intrinsic Acute Kidney Disease
Official title: A Diagnostic System of Clincial Model and Urinary Biomarkers for Intrinsic Acute Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Disease
Keywords: acute kidney disease
kidney biopsy
diagnostic model
urinary biomarkers
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Hebei University
name: Beijing Miyun Hospital
name: Dongzhimen Hospital, Beijing
name: Taiyuan Central Hospital of Shanxi Medical University
First posted: 2024-09-23
Enrollment: 1360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Apr. 30, 2024.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Histological diagnosis of AKD
timeFrame: within a week after biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Miyun District Hospital
state: Beijing
city: Baoding
country: China
facility: Affliated Hospital of Hebei University
state: Hebei
city: Taiyuan
country: China
facility: Taiyuan Central Hospital
state: Shanxi
Study officials:
affiliation: Peking University First Hospital
name: Li Yang, Professor
role: PRINCIPAL_INVESTIGATOR
References: