NCT06606522

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. 1.Can a clinical model comprised of common clinical indexes help diagnose AKD ?
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
Last Updated

September 23, 2024

Status Verified

August 1, 2024

Enrollment Period

29 days

First QC Date

September 9, 2024

Last Update Submit

September 18, 2024

Conditions

Acute Kidney Disease

Keywords

acute kidney diseasekidney biopsydiagnostic modelurinary biomarkers

Outcome Measures

Primary Outcomes (1)

  • Histological diagnosis of AKD

    Number of definite biopsy-proven histological diagnosis of AKD

    within a week after biopsy

Study Arms (2)

Derivation cohort

Patients from Peking University First Hospital

Diagnostic Test: Clinical modelDiagnostic Test: Urinary biomarkers

External Validation Cohort

Patients from other four centers

Diagnostic Test: Clinical modelDiagnostic Test: Urinary biomarkers

Interventions

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.

Derivation cohortExternal Validation Cohort
Urinary biomarkersDIAGNOSTIC_TEST

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

Derivation cohortExternal Validation Cohort

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Dec. 31, 2024.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dongzhimen Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100007, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Miyun District Hospital

Beijing, Beijing Municipality, 101520, China

Location

Affliated Hospital of Hebei University

Baoding, Hebei, 071000, China

Location

Taiyuan Central Hospital

Taiyuan, Shanxi, 030009, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples from patients with acute kidney disease

Study Officials

  • Li Yang, Professor

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 23, 2024

Study Start

June 1, 2024

Primary Completion

June 30, 2024

Study Completion

September 9, 2024

Last Updated

September 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)