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Methodological establishment and mechanism research of rapid grading assessment of chronic kidney disease based on serum-induced crystal morphology

Methodological establishment and mechanism research of rapid grading assessment of chronic kidney disease based on serum-induced crystal morphology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108986
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

CKD patients:none
Patients with isolated hematuria and proteinuria:none
Health control:none
Patients with diabetes mellitus only:none

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.CKD patients; 1.Voluntarily sign informed consent; 2.Age =18 years old; 3.Based on the patient's self-report, relevant laboratory tests, etc., it is determined that the patient is a CKD patient, with a clear CKD stage and the condition being in a stable state; 2.Patients with essential hypertension; 1.Age =18 years old; 2.Patients meeting the diagnostic criteria for hypertension without any other underlying diseases; 3.Patients with diabetes mellitus only; 1.Age =18 years old; 2.Patients meeting the diagnostic criteria for diabetes without any other underlying diseases; 4.Patients with isolated hematuria and proteinuria; 1.Age =18 years old; 2.Patients diagnosed with isolated hematuria and proteinuria with no other comorbidities; 5.Health control; 1.Voluntarily sign informed consent; 2.Age =18 years old; 3.A healthy control population from a physical check-up program with no known diseases and normal laboratory findings;

Exclusion criteria

Exclusion criteria: 1.CKD patients; 1.Acute kidney injury; patients undergoing dialysis or kidney transplantation; recent use of drugs that can affect creatinine levels; nephrotic syndrome; thyroid system diseases; severe edema or fluid balance disorders; severe heart, liver and lung dysfunction; infectious diseases; blood system diseases; malignant tumors at any site; pregnant women; lupus nephritis; 2.Samples with severe hemolysis and lipemia; 3.Poor image quality of the crystal; 4.According to the researchers' assessment, it was determined that they were not suitable to participate in this study; 2.Patients with essential hypertension; 1.eGFR<90 ml/(min×1.73m2); 2.Samples with severe hemolysis and lipemia; 3.Poor image quality of the crystal; 4.According to the researchers' assessment, it was determined that they were not suitable to participate in this study; 3.Patients with diabetes mellitus only; 1.eGFR<90 ml/(min×1.73m2); 2.Samples with severe hemolysis and lipemia; 3.Poor image quality of the crystal; 4.According to the researchers' assessment, it was determined that they were not suitable to participate in this study; 4.Patients with isolated hematuria and proteinuria; 1.Samples with severe hemolysis and lipemia; 2.Poor image quality of the crystal; 3.According to the researchers' assessment, it was determined that they were not suitable to participate in this study; 5.Health control; 1.Samples with severe hemolysis and lipemia; 2.Poor image quality of the crystal; 3.According to the researchers' assessment, it was determined that they were not suitable to participate in this study;

Design outcomes

Primary

MeasureTime frame
Sensitivity;Recall rate;Area under the Curve (AUC);F1 score;Specificity;Accuracy;Crystal morphology of uric acid;

Countries

China

Contacts

Public ContactBo Situ

Southern Medical University Southern Hospital

drstb@126.com+86 20 61641044

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026