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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Affiliated Hospital of Hebei University
Taiyuan Central Hospital of Shanxi Medical University
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing Miyun Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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