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Chronic kidney disease (CKD) is an irreversible change of kidney function and structure caused by many reasons. The main threat of CKD to human health is progressive renal function decline. Delaying the progression of chronic kidney disease to end-stage renal failure is an important clinical need, and renal fibrosis is a common pathway for the progression of chronic kidney disease to end-stage renal failure. The evaluation of renal fibrosis is of great value for the course and prognosis of patients with chronic kidney disease. However, pathological detection has the disadvantages of trauma, false negative, and cannot be implemented repeatedly. At present, there is a lack of effective non-invasive, dynamic, real-time monitoring and evaluation means. A commercially available FAP-targeted imaging agent, FAPI-04, has been used for PET/CT imaging of systemic fibrosis lesions with high uptake background in normal kidneys. Although it can show severe renal fibrosis, it is not conducive to the detection rate of patients with mild-moderate fibrosis who need more accurate evaluation. The new targeted FAP imaging agent successfully constructed by our research group has proved that it can show the degree of renal fibrosis at the living level and has correlation. Therefore, this study intends to carry out a series of clinical studies on the imaging of renal fibrosis with new targeted FAP probes, evaluate the specificity and sensitivity of the new targeted FAP probes in the diagnosis of renal fibrosis, and ultimately provide a new method for clinical dynamic, non-invasive assessment and monitoring of the degree and progression of renal fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAP-targeting PET/CT imaging | Experimental | FAP-targeting PET/CT imaging will be performed on the enrolled patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAP-targeting PET/CT imaging will be performed on the enrolled patients. | Other | FAP-targeting PET/CT imaging will be performed on the enrolled patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathological type | pathological type (e.g., sclerosing IgA nephropathy) | 1 week after enrollment |
| Baseline serum creatinine (μmol/L) | laboratory results | 1 month before enrollment and 1 month after enrollment |
| Baseline 24-hour urinary protein (g/24h) | laboratory results | 1 month before enrollment and 1 month after enrollment |
| Quantified renal pathological involvement. | Based on kidney biopsy sections, interstitial atrophy, interstitial inflammatory infiltration, and tubular fibrosis will be quantified. | 1 week after enrollment |
| Pathological MESTC score | MESTC score (0-2, for IgA nephropathy patients) | 1 week after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up serum creatinine (μmol/L) | laboratory results | From 1 month after enrollment to 60 month after enrollment |
| Proteinuria remisssion | For IgA nephropathy (IgAN) patients with baseline urinary total protein (UTP) exceeding 0.5 g/24h, a reduction of UTP to below 0.5 g/24h without recurrence within 4 weeks was considered proteinuria remission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | China |
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| From 1 month after enrollment to 60 month after enrollment |
| Acute kidney disease remission | For IgAN patients with AKD, AKD remission was defined as a reduction in SCr to below 75% of the peak value within 90 days after imaging. Remission was classified as complete if the difference between the last recorded SCr and baseline SCr was ≤26.5 μmol/L; otherwise, it was classified as partial. Baseline SCr was defined as the lowest value recorded within 90 days prior to hospital admission. If unavailable, the lowest SCr value within 90 days after admission was used as the baseline. | Within 3 month after enrollment |