CKDNCT06563765
FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis
A study testing FAP-targeting PET/CT imaging will be performed on the enrolled patients. in people with CKD and Renal Fibrosis, run by Peking University First Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Renal Fibrosis
- What is being tested?
- FAP-targeting PET/CT imaging will be performed on the enrolled patients.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic kidney disease
- Renal pathology was performed within 2 weeks
Who cannot join
- Pregnant or lactating patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- CKD, Renal Fibrosis
- Being tested
- FAP-targeting PET/CT imaging will be performed on the enrolled patients.
- Keywords
- CKD, Renal fibrosis, FAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| FAP-targeting PET/CT imaging | Experimental | FAP-targeting PET/CT imaging will be performed on the enrolled patients. Receives: Other: FAP-targeting PET/CT imaging will be performed on the enrolled patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological type
pathological type (e.g., sclerosing IgA nephropathy)
Measured: 1 week after enrollment
Baseline serum creatinine (μmol/L)
laboratory results
Measured: 1 month before enrollment and 1 month after enrollment
Baseline 24-hour urinary protein (g/24h)
laboratory results
Measured: 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.
Measured: 1 week after enrollment
Pathological MESTC score
MESTC score (0-2, for IgA nephropathy patients)
Measured: 1 week after enrollment
Secondary outcomes (3)
Follow-up serum creatinine (μmol/L)
laboratory results
Measured: 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.
Measured: 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.
Measured: Within 3 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 Apr 2024
- Primary completion10 May 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563765
- Sponsor's protocol ID
- 2022-386
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis
- ClinicalTrials.gov ID
- NCT06563765
- Acronym / sponsor ID
- 2022-386
- Conditions
- CKD, Renal Fibrosis
- Keywords
- CKD, Renal fibrosis, FAP
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAP-targeting PET/CT imaging | Experimental | Other: FAP-targeting PET/CT imaging will be performed on the enrolled patients.FAP-targeting PET/CT imaging will be performed on the enrolled patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic kidney disease
- Renal pathology was performed within 2 weeks
Key exclusion criteria (1 listed)
- Pregnant or lactating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAP-targeting PET/CT imaging will be performed on the enrolled patients.FAP-targeting PET/CT imaging will be performed on the enrolled patients. | Other | FAP-targeting PET/CT imaging |
Primary outcome
Pathological type
Time frame: 1 week after enrollment
pathological type (e.g., sclerosing IgA nephropathy)
Baseline serum creatinine (μmol/L)
Time frame: 1 month before enrollment and 1 month after enrollment
laboratory results
Baseline 24-hour urinary protein (g/24h)
Time frame: 1 month before enrollment and 1 month after enrollment
laboratory results
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.
Pathological MESTC score
Time frame: 1 week after enrollment
MESTC score (0-2, for IgA nephropathy patients)
3 secondary outcomes
Follow-up serum creatinine (μmol/L)
Time frame: From 1 month after enrollment to 60 month after enrollment
Proteinuria remisssion
Time frame: From 1 month after enrollment to 60 month after enrollment
Acute kidney disease remission
Time frame: Within 3 month after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAP-targeting PET/CT imaging will be performed on the enrolled patients. in people with CKD and Renal Fibrosis, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological type (time frame: 1 week after enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.