Chronic Kidney Disease, CKD
Conditions
Interventions
Gold Standard:Plasma method GFR measurement
Index test:CZT-SPECT/CT GFR Measurement
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 80 years old (inclusive); 2.Diagnosis: Diagnosed with chronic kidney disease (CKD) meeting the KDIGO diagnostic criteria, with a disease course of >= 3 months; 3.Etiology: Confirmed etiology of CKD, belonging to one of the following: diabetic kidney disease, hypertensive renal damage, or chronic obstructive nephropathy (confirmed by imaging and clinically stable); 4.Renal Function: Estimated glomerular filtration rate (eGFR, based on the CKD-EPI formula) between 30 and 59 mL/min/1.73 m^2 (CKD Stage 3); 5.Clinical Indication: Clear clinical indication for GFR evaluation, with plans to undergo ^99mTc-DTPA dynamic renal imaging; 6.Stability: Relatively stable renal function within 2 weeks prior to study enrollment (fluctuation in serum creatinine < 15%); 7.Consent: Capable of understanding the study purpose, participating voluntarily, and providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Known history of severe allergic reaction to ^99mTc-DTPA; 3. Severe heart, lung, liver, or other organ dysfunction (such as NYHA class III–IV heart failure, severe respiratory insufficiency, Child-Pugh class C cirrhosis); 4. History of kidney cancer, or currently having active malignancy; 5. Previous kidney surgery that may significantly affect kidney function assessment (such as nephrectomy or kidney transplant); 6. Having a single kidney, severe kidney malformation, or ectopic kidney, affecting the accuracy of GFR measurement; 7. Severe water and electrolyte disorders or diseases affecting blood creatinine levels (such as severe malnutrition, muscular dystrophy, or uncontrolled thyroid dysfunction); 8. Claustrophobia or inability to cooperate with imaging tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency between GFR (mGFR) measured by CZT whole-ring SPECT/CT dynamic imaging and reference GFR (tGFR) obtained by plasma method; | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between mGFR and tGFR;The bias, precision, and accuracy of mGFR and the estimated GFR (eGFR) calculated using different formulas (CKD-EPI 2021, Bedside Schwartz, and CKiD) compared to tGFR.; | — |
Countries
China
Contacts
Public ContactMin Zhao
The Third Xiangya Hospital Central South University
Outcome results
None listed