Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06563765

FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic kidney disease
  • Renal pathology was performed within 2 weeks

Exclusion criteria

  • Pregnant or lactating patients

Treatment and study plan

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.

Primary outcomes

  1. Pathological type

    Time frame: 1 week after enrollment

    pathological type (e.g., sclerosing IgA nephropathy)

  2. Baseline serum creatinine (μmol/L)

    Time frame: 1 month before enrollment and 1 month after enrollment

    laboratory results

  3. Baseline 24-hour urinary protein (g/24h)

    Time frame: 1 month before enrollment and 1 month after enrollment

    laboratory results

  4. Quantified renal pathological involvement.

    Time frame: 1 week after enrollment

    Based on kidney biopsy sections, interstitial atrophy, interstitial inflammatory infiltration, and tubular fibrosis will be quantified.

  5. Pathological MESTC score

    Time frame: 1 week after enrollment

    MESTC score (0-2, for IgA nephropathy patients)

Secondary outcomes

  1. Follow-up serum creatinine (μmol/L)

    Time frame: From 1 month after enrollment to 60 month after enrollment

    laboratory results

  2. Proteinuria remisssion

    Time frame: From 1 month after enrollment to 60 month after enrollment

    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.

  3. Acute kidney disease remission

    Time frame: Within 3 month after enrollment

    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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.