Lupus NephritisNCT05845151
Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis
A study testing 68Ga-FAPI-04 PET in people with Lupus Nephritis, run by Ruijin Hospital at 1 site in China.
Trial summary
Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- 68Ga-FAPI-04 PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18-80 years old;
- Confirmed SLE: meet the 2019 EULAR/ACR classification standards;
- There are signs of renal involvement and indications for renal puncture: proteinuria> 0.5g/24 hours (or urine protein creatine ratio (UPCR) >500mg/g), unexplained decrease of glomerular filtration rate (GFR)
Who cannot join
- The pathology of renal puncture is not consistent with lupus nephritis;
- Previous history of other kidney diseases;
- There are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney;
- History of malignant tumors within 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Min Zhang, Dr., 0086-21-64370045, zm11518@rjh.com.cn
About this study
Official title: Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis
Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.
- Conditions
- Lupus Nephritis
- Being tested
- 68Ga-FAPI-04 PET
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-04 PETDiagnostic test
Activation of renal fibroblast is quantified using 68Ga-FAPI-04 PET in patients with LN.
| Study group | Role | What they receive |
|---|---|---|
| LN Patients group | Experimental | Not described Receives: Diagnostic Test: 68Ga-FAPI-04 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Measured: Baseline
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Measured: 6 months after baseline
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Measured: 12 months after baseline
Renal FAP expression level
Quantitative assessment of renal fibroblast activation on FAPI PET image
Measured: 24 months after baseline
Secondary outcomes (2)
Renal fibrosis score
It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome.
Measured: Baseline
Chronic activity score
It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Shi, Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845151
- Sponsor's protocol ID
- (2021)CER(87)
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT05845151
- Acronym / sponsor ID
- (2021)CER(87)
- Conditions
- Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 May 2023 (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.
Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LN Patients group | Experimental | Diagnostic Test: 68Ga-FAPI-04 PET |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be between 18-80 years old;
- Confirmed SLE: meet the 2019 EULAR/ACR classification standards;
- There are signs of renal involvement and indications for renal puncture: proteinuria> 0.5g/24 hours (or urine protein creatine ratio (UPCR) >500mg/g), unexplained decrease of glomerular filtration rate (GFR)
Key exclusion criteria (4 listed)
- The pathology of renal puncture is not consistent with lupus nephritis;
- Previous history of other kidney diseases;
- There are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney;
- History of malignant tumors within 5 years.
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 |
|---|---|---|
| 68Ga-FAPI-04 PETActivation of renal fibroblast is quantified using 68Ga-FAPI-04 PET in patients with LN. | Diagnostic test | LN Patients group |
Primary outcome
Renal FAP expression level
Time frame: Baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Time frame: 6 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Time frame: 12 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
Renal FAP expression level
Time frame: 24 months after baseline
Quantitative assessment of renal fibroblast activation on FAPI PET image
2 secondary outcomes
Renal fibrosis score
Time frame: Baseline
Chronic activity score
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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. This study is not recruiting at the moment.
Hui Shi, Dr. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI-04 PET in people with Lupus Nephritis, run by Ruijin 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Shi, Dr. (0086 21 64370045, shihui_sjtu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal FAP expression level (time frame: Baseline). The study lists 4 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 6 May 2023.