Acute Kidney DiseaseNCT06606522
A Clinical Diagnostic System for Intrinsic Acute Kidney Disease
An observational study of Acute Kidney Disease, run by Peking University First Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Disease
- What is being tested?
- Clinical model and Urinary biomarkers
- How many people
- 1,360 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jun 2024to 9 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Apr. 30, 2024.
Who may be able to join
- Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Dec. 31, 2024.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Affliated Hospital of Hebei University
Baoding, Hebei, 071000
Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100007
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Miyun District Hospital
Beijing, Beijing Municipality, 101520
Taiyuan Central Hospital
Taiyuan, Shanxi, 030009
About this study
Official title: 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:
- Can a clinical model comprised of common clinical indexes help diagnose AKD ?
- 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.
Read the 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.
- Conditions
- Acute Kidney Disease
- Being tested
- Clinical model, Urinary biomarkers
- Keywords
- acute kidney disease, kidney biopsy, diagnostic model, urinary biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical modelDiagnostic 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 biomarkersDiagnostic test
Urinary biomarkers: biomarkers help differentiate different pathological types of intrinsic AKD.
| Study group | Role | What they receive |
|---|---|---|
| Derivation cohort | Patients from Peking University First Hospital Receives: Diagnostic Test: Clinical model; Diagnostic Test: Urinary biomarkers | |
| External Validation Cohort | Patients from other four centers Receives: Diagnostic Test: Clinical model; Diagnostic Test: Urinary biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological diagnosis of AKD
Number of definite biopsy-proven histological diagnosis of AKD
Measured: within a week after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jun 2024
- Primary completion30 Jun 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Beijing Miyun Hospital, Dongzhimen Hospital, Beijing, Taiyuan Central Hospital of Shanxi Medical University
- Responsible party
- Principal investigator, Li Yang, Peking University First Hospital
- Investigators
- Li Yang, Professor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606522
- Sponsor's protocol ID
- 2024-379-002
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic System of Clincial Model and Urinary Biomarkers for Intrinsic Acute Kidney Disease
- ClinicalTrials.gov ID
- NCT06606522
- Acronym / sponsor ID
- 2024-379-002
- Conditions
- Acute Kidney Disease
- Keywords
- acute kidney disease, kidney biopsy, diagnostic model, urinary biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Beijing Miyun Hospital, Dongzhimen Hospital, Beijing, Taiyuan Central Hospital of Shanxi Medical University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can a clinical model comprised of common clinical indexes help diagnose AKD ?
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation cohort | – | Diagnostic Test: Clinical model, Diagnostic Test: Urinary biomarkersPatients from Peking University First Hospital |
| External Validation Cohort | – | Diagnostic Test: Clinical model, Diagnostic Test: Urinary biomarkersPatients from other four centers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Apr. 30, 2024.
Key inclusion criteria (1 listed)
- Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Dec. 31, 2024.
Key exclusion criteria (5 listed)
- Patients were excluede if they
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical modelClinical model: a clinical model based on basic demorgraphic information and commonly executed laboratory tests to differentiate different pathological types of intrinsic AKD. | Diagnostic test | Derivation cohort, External Validation Cohort |
| Urinary biomarkersUrinary biomarkers: biomarkers help differentiate different pathological types of intrinsic AKD. | Diagnostic test | Derivation cohort, External Validation Cohort |
Primary outcome
Histological diagnosis of AKD
Time frame: within a week after biopsy
Number of definite biopsy-proven histological diagnosis of AKD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Yang, Professor principal investigator
Peking University First Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Disease, run by Peking University First Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological diagnosis of AKD (time frame: within a week after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.