ClinicalTrials.gg
Enrolling by invitationNCT07645794Updated Sep 23, 2026

Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF

An observational study in Chronic Kidney Disease and Osteoporosis, sponsored by Capital Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Capital Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
868
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 243 studies in Renal Insufficiency, Chronic with a site in China — 92 open to participants now, 105 under way, 16 of them phase 3. Renal Insufficiency, Chronic · China.

Planned enrollment
45th of 80
868 · median 1,350
Started
2026
with 24 others
Observational
80 of 243
40 open now
Primary completion
2028-12
later than 78 of 104 live
Registered
231st of 243
by date

Among the 243 studies in Renal Insufficiency, Chronic with a site in China, this one is the 45th largest by planned enrollment of the 80 observational ones, is one of 25 that started in 2026, is one of 80 observational ones, reaches primary completion later than 78 of the 104 other live ones, and was the 231st registered.

By phase

243 studies; the count open now beside each. This study's row is marked.

Observationalthis study80 · 40 open
No phase43 · 14 open
Phase 338 · 11 open
Phase 438 · 12 open
Phase 222 · 5 open
Phase 120 · 10 open
Phase 1/22 · 0 open

By the year they started

First in 2000; this study’s year is marked. 25 started in 2026.

Size and results

Median enrollment 182 across the 162 interventional studies, 1,350 across the 80 observational. Of the 84 that completed or were terminated, 21 (25%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 243 studies in Renal Insufficiency, Chronic with a site in China, or all of them as a file.
02

Study 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). 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.

03

Conditions studied

  • Chronic Kidney Disease
  • Osteoporosis

Keywords

  • Chronic Kidney Disease
  • Osteoporosis
  • Sarcopenia
  • MRI-FF
  • Bone Mineral Density
  • Muscle Fat Fraction
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 18 and 80 years old.
  2. Able to understand and sign the form.
  3. Able to complete MRI-FF scans of the lumbar spine and thigh.
  4. For CKD group: Confirmed diagnosis of chronic kidney disease ( \< 60 mL/min/1.73m² for ≥3 months).
  5. For control group: No history of chronic kidney disease and normal renal function.

Exclusion criteria

Exclusion Criteria:

  1. to MRI (e.g., pacemaker, metal implants, severe claustrophobia).
  2. History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.
  3. Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).
  4. Severe lower limb deformity or amputation affecting thigh muscle assessment.
  5. Inability to cooperate with the scan due to cognitive impairment or severe illness.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
868 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    Other: MRI-FF Scan

Interventions

  • OtherMRI-FF Scan

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the time of the MRI-FF scan (baseline, one-time assessment)

  2. 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.

    Time frame: At the time of the MRI-FF scan (baseline, one-time assessment)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.

Of 274 non-industry observational studies under Renal Insufficiency, Chronic, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 29 months is below that.

Counting every sponsor, half of 325 studies reached it within 45 months; a quarter within 22 and three quarters within 191.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jun 12, 2026
StartActual
Jun 28, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07645794
Responsible party
Dongliang Zhang, MD (Chief Physician, Professor, Department of Nephrology, Capital Medical University) — Principal investigator
First posted
Jun 12, 2026
Start date
Jun 28, 2026
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Dongliang Zhang, MD
study director · Beijing Jishuitan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion