A Clinical Diagnostic System for Intrinsic Acute Kidney Disease

NCT ID: NCT06606522

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-09-09

Brief Summary

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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

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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.

Conditions

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Acute Kidney Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Derivation cohort

Patients from Peking University First Hospital

Clinical model

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

External Validation Cohort

Patients from other four centers

Clinical model

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Clinical model

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

Intervention Type DIAGNOSTIC_TEST

Urinary biomarkers

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Hebei University

OTHER

Sponsor Role collaborator

Beijing Miyun Hospital

UNKNOWN

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Taiyuan Central Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Yang, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Dongzhimen Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Miyun District Hospital

Beijing, Beijing Municipality, China

Site Status

Affliated Hospital of Hebei University

Baoding, Hebei, China

Site Status

Taiyuan Central Hospital

Taiyuan, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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2024-379-002

Identifier Type: -

Identifier Source: org_study_id

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