Chronic Kidney DiseaseNCT07645794
Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF
An observational study of Chronic Kidney Disease and Osteoporosis, run by Capital Medical University at 1 site in China.
Trial summary
This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Osteoporosis
- What is being tested?
- MRI-FF Scan
- How many people
- 868 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2026to 31 Dec 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of two groups: 434 patients with chronic kidney disease (CKD) and 434 age- and sex-matched healthy controls without CKD. All participants are adults aged 18-80 years old who are able to complete the required MRI scans.
Who may be able to join
- Age between 18 and 80 years old.
- Able to understand and sign the informed consent form.
- Able to complete MRI-FF scans of the lumbar spine and thigh.
- For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR < 60 mL/min/1.73m² for ≥3 months).
- For control group: No history of chronic kidney disease and normal renal function.
Who cannot join
- Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia).
- History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.
- Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).
- Severe lower limb deformity or amputation affecting thigh muscle assessment.
- Inability to cooperate with the scan due to cognitive impairment or severe illness.
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
Nephrology Department of Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
About this study
Official title: A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR
This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.
- Conditions
- Chronic Kidney Disease, Osteoporosis
- Being tested
- MRI-FF Scan
- Keywords
- Chronic Kidney Disease, Osteoporosis, Sarcopenia, MRI-FF, Bone Mineral Density, Muscle Fat Fraction
- Medical subject headings
- Renal Insufficiency, Chronic, Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-FF ScanOther
MRI fat-fraction (MRI-FF) scan of the lumbar spine and thigh, performed once for all participants to assess bone mineral density and muscle fat fraction.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease (CKD) Group | Patients with chronic kidney disease (CKD) who undergo MRI-FF scans of the lumbar spine and thigh to evaluate bone mineral density and muscle fat fraction. Receives: Other: MRI-FF Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between MRI-FF-derived bone mineral density and DXA measurements
The primary outcome is the correlation coefficient between MRI fat-fraction (MRI-FF) parameters and standard dual-energy X-ray absorptiometry (DXA) bone mineral density values in the lumbar spine of CKD patients and controls.
Measured: At the time of the MRI-FF scan (baseline, one-time assessment)
Diagnostic performance of MRI-FF for sarcopenia using muscle fat fraction
The secondary outcome is the diagnostic accuracy (sensitivity, specificity, AUC) of MRI-FF-derived thigh muscle fat fraction in identifying sarcopenia, based on standard diagnostic criteria.
Measured: At the time of the MRI-FF scan (baseline, one-time assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start28 Jun 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Capital Medical 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
- 868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongliang Zhang, MD, Capital Medical University
- Investigators
- Dongliang Zhang, MD, Study director, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645794
- Sponsor's protocol ID
- 2026-2-1064
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR
- ClinicalTrials.gov ID
- NCT07645794
- Acronym / sponsor ID
- 2026-2-1064
- Conditions
- Chronic Kidney Disease, Osteoporosis
- Keywords
- Chronic Kidney Disease, Osteoporosis, Sarcopenia, MRI-FF, Bone Mineral Density, Muscle Fat Fraction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 868 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 28 Jun 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jun 2026 (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 is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) Group | – | Other: MRI-FF ScanPatients with chronic kidney disease (CKD) who undergo MRI-FF scans of the lumbar spine and thigh to evaluate bone mineral density and muscle fat fraction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of two groups: 434 patients with chronic kidney disease (CKD) and 434 age- and sex-matched healthy controls without CKD. All participants are adults aged 18-80 years old who are able to complete the required MRI scans.
Key inclusion criteria (5 listed)
- Age between 18 and 80 years old.
- Able to understand and sign the informed consent form.
- Able to complete MRI-FF scans of the lumbar spine and thigh.
- For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR < 60 mL/min/1.73m² for ≥3 months).
- For control group: No history of chronic kidney disease and normal renal function.
Key exclusion criteria (5 listed)
- Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia).
- History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.
- Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).
- Severe lower limb deformity or amputation affecting thigh muscle assessment.
- Inability to cooperate with the scan due to cognitive impairment or severe illness.
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 |
|---|---|---|
| MRI-FF ScanMRI fat-fraction (MRI-FF) scan of the lumbar spine and thigh, performed once for all participants to assess bone mineral density and muscle fat fraction. | Other | Chronic Kidney Disease (CKD) Group |
Primary outcome
Correlation between MRI-FF-derived bone mineral density and DXA measurements
Time frame: At the time of the MRI-FF scan (baseline, one-time assessment)
The primary outcome is the correlation coefficient between MRI fat-fraction (MRI-FF) parameters and standard dual-energy X-ray absorptiometry (DXA) bone mineral density values in the lumbar spine of CKD patients and controls.
Diagnostic performance of MRI-FF for sarcopenia using muscle fat fraction
Time frame: At the time of the MRI-FF scan (baseline, one-time assessment)
The secondary outcome is the diagnostic accuracy (sensitivity, specificity, AUC) of MRI-FF-derived thigh muscle fat fraction in identifying sarcopenia, based on standard diagnostic criteria.
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 23 Sep 2026.
- 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.
Dongliang Zhang, MD study director
Beijing Jishuitan Hospital
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 Osteoporosis, run by Capital Medical 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 5 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 23 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?
Correlation between MRI-FF-derived bone mineral density and DXA measurements (time frame: At the time of the MRI-FF scan (baseline, one-time assessment)). 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 23 Sep 2026.