Chronic Kidney DiseaseNCT07107919
Multimodal Imaging Assessment of Chronic Kidney Disease Patients at Different Stages From a Cardio-Renal Interaction Perspective
An observational study of Chronic Kidney Disease and Cardiac Magnetic Resonance, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study is a prospective cohort investigation in which consecutive eligible patients undergo 18F-FAPI PET/MR imaging. Chronic kidney disease (CKD) participants are stratified into two groups:Group I ：CKD stages 1-3（eGFR ≥ 30 mL/min/1.73 m²）,Group II :CKD stages 4-5(eGFR < 30 mL/min/1.73 m²). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Cardiac Magnetic Resonance, 18F-FAPI
- What is being tested?
- 18F PET/MR
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 1 Jun 2027
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 80 years with clinically diagnosed chronic kidney disease (CKD), classified according to the KDIGO guidelines. Participants will be stratified into two groups based on renal function: Group I (CKD stages 1-3, eGFR ≥ 30 mL/min/1.73 m²) and Group II (CKD stages 4-5, eGFR < 30 mL/min/1.73 m²). Subjects will be consecutively recruited from the Department of Nephrology and Cardiology of The Affiliated Hospital of Qingdao University. Both male and female patients will be included.
Who may be able to join
- Age between 18 and 80 years, regardless of sex.
- Clinically diagnosed with chronic kidney disease (CKD), based on KDIGO guidelines.
- Complete clinical data available.
- Written informed consent for participation and for undergoing 18F-FAPI PET/MR imaging is obtained from the patient or their legal guardian.
- Female participants must agree to use effective contraception during the study and for at least 6 months after its completion (e.g., sterilization, intrauterine hormonal devices, condoms, hormonal contraceptives, abstinence, or vasectomized partner). Male participants must also agree to use contraception during the study and for 6 months after its completion.
Who cannot join
- Women who are planning to conceive, currently pregnant, or breastfeeding.
- Contraindications to PET/MR imaging, including but not limited to metal implants, claustrophobia, or inability to tolerate cardiac MRI due to respiratory difficulties.
- History of allergy or hypersensitivity to gadolinium-based contrast agents.
- Presence of malignant tumors or other serious progressive diseases.
- Patients with severe cardiac conditions, such as advanced heart failure, severe valvular disease, or cardiomyopathies.
- Hemodynamic instability.
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- Presence of severe systemic or localized infections, or other serious comorbid conditions.
- Incomplete clinical data.
- Any other reason deemed by the investigators to make the subject unsuitable for participation, including inability or unwillingness to comply with study procedures and requirements.
- Determined by the investigators to be inappropriate for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Pei Nie, MD, niepei@qdu.edu.cn
About this study
This study is a prospective cohort investigation in which consecutive eligible patients undergo 18F-FAPI PET/MR imaging. Chronic kidney disease (CKD) participants are stratified into two groups:Group I ：CKD stages 1-3（eGFR ≥ 30 mL/min/1.73 m²）,Group II :CKD stages 4-5(eGFR < 30 mL/min/1.73 m²).
Using 18F-FAPI PET/MR, we will evaluate global cardiac functional impairment and myocardial fibrosis characteristics, and analyze their associations with the degree of renal dysfunction.
- Conditions
- Chronic Kidney Disease, Cardiac Magnetic Resonance, 18F-FAPI
- Being tested
- 18F PET/MR
- Keywords
- CKD, Cardiac Magnetic Resonance, 18F-FAPI
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F PET/MROther
Tracer: ^18F FAPI 04 is used in this study. A single intravenous bolus dose of 3.70-4.44 MBq/kg is administered.
- Simultaneous PET/MR Acquisition: During PET imaging, cardiac MR (CMR) is performed in the supine position. All images are acquired with ECG gating and respiratory gating, during end expiratory breath holds.
- Cardiac Morphology and Function (Localization \& Cine):Assess cardiac structure and global/regional function
- T2 Weighted Fat Suppressed Imaging:Evaluate myocardial edema
- First Pass Perfusion Imaging:Quantitatively assess the extent and severity of myocardial perfusion defects
- Late Gadolinium Enhancement (LGE): Detect and quantify myocardial necrosis and fibrosis
- T1 Mapping (Pre and Post Contrast): Quantify myocardial interstitial fibrosis
- T2 Mapping (Pre Contrast):Quantify myocardial edema
- Cardiac PET Imaging:Evaluate myocardial fibrosis characteristics using ^18F FAPI PET data
| Study group | Role | What they receive |
|---|---|---|
| Group I (CKD stages 1-3) | eGFR ≥ 30 mL/min/1.73 m² Receives: Other: 18F PET/MR | |
| Group II (CKD stages 4-5) | eGFR < 30 mL/min/1.73 m² Receives: Other: 18F PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial fibrosis burden measured by 18F-FAPI PET/MR
Myocardial uptake of 18F-FAPI quantified using SUVmax and SUVmean values from PET imaging.
Measured: At baseline (within 1 week of enrollment)
Myocardial fibrosis burden measured by 18F-FAPI PET/MR
Native T1 value, ECV, and LGE assessed by cardiac MRI to evaluate myocardial fibrosis
Measured: At baseline (within 1 week of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start30 Jul 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei Nie, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107919
- Sponsor's protocol ID
- QYFYEC2025-103
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Assessment of Chronic Kidney Disease Patients at Different Stages From a Cardio-Renal Interaction Perspective
- ClinicalTrials.gov ID
- NCT07107919
- Acronym / sponsor ID
- QYFYEC2025-103
- Conditions
- Chronic Kidney Disease, Cardiac Magnetic Resonance, 18F-FAPI
- Keywords
- CKD, Cardiac Magnetic Resonance, 18F-FAPI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
This study is a prospective cohort investigation in which consecutive eligible patients undergo 18F-FAPI PET/MR imaging. Chronic kidney disease (CKD) participants are stratified into two groups:Group I ：CKD stages 1-3（eGFR ≥ 30 mL/min/1.73 m²）,Group II :CKD stages 4-5(eGFR < 30 mL/min/1.73 m²).
Using 18F-FAPI PET/MR, we will evaluate global cardiac functional impairment and myocardial fibrosis characteristics, and analyze their associations with the degree of renal dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (CKD stages 1-3) | – | Other: 18F PET/MReGFR ≥ 30 mL/min/1.73 m² |
| Group II (CKD stages 4-5) | – | Other: 18F PET/MReGFR < 30 mL/min/1.73 m² |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 80 years with clinically diagnosed chronic kidney disease (CKD), classified according to the KDIGO guidelines. Participants will be stratified into two groups based on renal function: Group I (CKD stages 1-3, eGFR ≥ 30 mL/min/1.73 m²) and Group II (CKD stages 4-5, eGFR < 30 mL/min/1.73 m²). Subjects will be consecutively recruited from the Department of Nephrology and Cardiology of The Affiliated Hospital of Qingdao University. Both male and female patients will be included.
Key inclusion criteria (5 listed)
- Age between 18 and 80 years, regardless of sex.
- Clinically diagnosed with chronic kidney disease (CKD), based on KDIGO guidelines.
- Complete clinical data available.
- Written informed consent for participation and for undergoing 18F-FAPI PET/MR imaging is obtained from the patient or their legal guardian.
- Female participants must agree to use effective contraception during the study and for at least 6 months after its completion (e.g., sterilization, intrauterine hormonal devices, condoms, hormonal contraceptives, abstinence, or vasectomized partner). Male participants must also agree to use contraception during the study and for 6 months after its completion.
Key exclusion criteria (10 listed)
- Women who are planning to conceive, currently pregnant, or breastfeeding.
- Contraindications to PET/MR imaging, including but not limited to metal implants, claustrophobia, or inability to tolerate cardiac MRI due to respiratory difficulties.
- History of allergy or hypersensitivity to gadolinium-based contrast agents.
- Presence of malignant tumors or other serious progressive diseases.
- Patients with severe cardiac conditions, such as advanced heart failure, severe valvular disease, or cardiomyopathies.
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 |
|---|---|---|
| 18F PET/MRTracer: ^18F FAPI 04 is used in this study. A single intravenous bolus dose of 3.70-4.44 MBq/kg is administered. • Simultaneous PET/MR Acquisition: During PET imaging, cardiac MR (CMR) is performed in the supine position. All images are acquired with ECG gating and respiratory gating, during end expiratory breath holds. 1. Cardiac Morphology and Function (Localization \& Cine):Assess cardiac structure and global/regional function 2. T2 Weighted Fat Suppressed Imaging:Evaluate myocardial edema 3. First Pass Perfusion Imaging:Quantitatively assess the extent and severity of myocardial perfusion defects 4. Late Gadolinium Enhancement (LGE): Detect and quantify myocardial necrosis and fibrosis 5. T1 Mapping (Pre and Post Contrast): Quantify myocardial interstitial fibrosis 6. T2 Mapping (Pre Contrast):Quantify myocardial edema 7. Cardiac PET Imaging:Evaluate myocardial fibrosis characteristics using ^18F FAPI PET data | Other | Group I (CKD stages 1-3), Group II (CKD stages 4-5) |
Primary outcome
Myocardial fibrosis burden measured by 18F-FAPI PET/MR
Time frame: At baseline (within 1 week of enrollment)
Myocardial uptake of 18F-FAPI quantified using SUVmax and SUVmean values from PET imaging.
Myocardial fibrosis burden measured by 18F-FAPI PET/MR
Time frame: At baseline (within 1 week of enrollment)
Native T1 value, ECV, and LGE assessed by cardiac MRI to evaluate myocardial fibrosis
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 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Pei Nie principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Cardiac Magnetic Resonance, run by The Affiliated Hospital of Qingdao University 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. 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?
Contact Pei Nie, MD (+86 0532-821592, niepei@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial fibrosis burden measured by 18F-FAPI PET/MR (time frame: At baseline (within 1 week of enrollment)). The study lists 2 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 Aug 2025.