A Clinical Diagnostic System for Intrinsic Acute Kidney Disease

September 18, 2024 updated by: Li Yang, Peking University First Hospital

A Diagnostic System of Clincial Model and Urinary Biomarkers 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100007
        • Dongzhimen Hospital of Beijing University of Chinese Medicine
      • Beijing, Beijing, China, 101520
        • Beijing Miyun District Hospital
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affliated Hospital of Hebei University
    • Shanxi
      • Taiyuan, Shanxi, China, 030009
        • Taiyuan Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Apr. 30, 2024.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Derivation cohort
Patients from Peking University First Hospital
Diagnostic test: 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.
Diagnostic test: Urinary biomarkers
Urinary biomarkers: biomarkers help differentiate different pathological types of intrinsic AKD.
External Validation Cohort
Patients from other four centers
Diagnostic test: 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.
Diagnostic test: Urinary biomarkers
Urinary biomarkers: biomarkers help differentiate different pathological types of intrinsic AKD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological diagnosis of AKD
Time Frame: within a week after biopsy
Number of definite biopsy-proven histological diagnosis of AKD
within a week after biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

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

Investigators

  • Principal Investigator: Li Yang, Professor, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-379-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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