SarcopeniaKT-SARCNCT07607236
Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients
An observational study of Sarcopenia and Kidney Transplantation, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
This is a single-center prospective observational study designed to evaluate the effectiveness of multimodal muscle ultrasound for the assessment of sarcopenia in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sarcopenia, Kidney Transplantation, Muscle Wasting
- What is being tested?
- Muscle Ultrasound
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult kidney transplant recipients undergoing perioperative sarcopenia assessment at Sichuan Provincial People's Hospital.
Who may be able to join
- Adult patients aged 18 years or older
- Patients scheduled to undergo kidney transplantation
- Ability to undergo muscle ultrasound and bioelectrical impedance analysis (BIA)
- Ability to provide written informed consent
Who cannot join
- Patients with severe limb deformity or conditions preventing muscle ultrasound assessment
- Patients with implanted electronic devices contraindicating BIA assessment
- Inability to complete study assessments
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
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Yifu Hou, MD, PhD, +86-18980732072, houyifu0726@foxmail.com
About this study
Official title: A Prospective Observational Study of Multimodal Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients
This is a single-center prospective observational study designed to evaluate the effectiveness of multimodal muscle ultrasound for the assessment of sarcopenia in kidney transplant recipients. Adult patients undergoing kidney transplantation will undergo both muscle ultrasound and bioelectrical impedance analysis (BIA) at predefined time points before and after transplantation.
The primary objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment, including its correlation and agreement with BIA-derived skeletal muscle index (BIA-SMI), as well as its diagnostic accuracy. Secondary objectives include describing the longitudinal changes in sarcopenia prevalence and muscle-related parameters from the pre-transplant period to 1 year after transplantation.
The study aims to provide evidence for a convenient, noninvasive, radiation-free, and reliable method for sarcopenia assessment in kidney transplant recipients.
Read the detailed description
Sarcopenia is highly prevalent among patients with end-stage renal disease and is associated with poor clinical outcomes. Although kidney transplantation may improve overall health status, perioperative stress, immunosuppressive therapy, and postoperative metabolic changes may influence muscle mass and function. Reliable assessment of sarcopenia in kidney transplant recipients remains clinically important.
Current methods for sarcopenia assessment include computed tomography (CT), dual-energy X-ray absorptiometry (DXA), and bioelectrical impedance analysis (BIA). However, CT and DXA are limited by radiation exposure, cost, and accessibility, while BIA may be affected by changes in hydration status, especially in transplant recipients. Muscle ultrasound is a portable, radiation-free, and bedside-available imaging modality that may provide a practical alternative for muscle assessment.
This prospective observational study will enroll adult kidney transplant recipients at Sichuan Provincial People's Hospital. Participants will undergo multimodal muscle ultrasound and BIA examinations at predefined perioperative time points. Ultrasound parameters will include muscle thickness, cross-sectional area, and echogenicity.
The primary study objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard. Correlation analysis, intraclass correlation coefficients, Bland-Altman analysis, and receiver operating characteristic (ROC) curve analysis will be performed to evaluate agreement and diagnostic accuracy.
Secondary objectives include evaluating longitudinal changes in muscle-related parameters and sarcopenia prevalence from the pre-transplant period to 1 year after kidney transplantation. Linear mixed-effects models or generalized estimating equations will be used to analyze temporal trends.
This study aims to establish muscle ultrasound as a practical and reliable tool for sarcopenia assessment in kidney transplant recipients and to improve understanding of perioperative muscle changes after transplantation.
- Conditions
- Sarcopenia, Kidney Transplantation, Muscle Wasting
- Being tested
- Muscle Ultrasound
- Keywords
- Muscle Ultrasound, Bioelectrical Impedance Analysis, BIA-SMI, Kidney Transplant Recipient, Muscle Mass, Frailty, Prospective Cohort
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle UltrasoundDiagnostic test
Multimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients | Adult kidney transplant recipients undergoing prospective assessment of sarcopenia using multimodal muscle ultrasound and bioelectrical impedance analysis (BIA). Receives: Diagnostic Test: Muscle Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic (ROC) curve of muscle ultrasound for detecting sarcopenia using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard.
Diagnostic performance of multimodal muscle ultrasound for sarcopenia assessment using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard, including receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
Measured: From baseline to 1 year after kidney transplantation
Secondary outcomes (3)
Change in Muscle Thickness Measured by Ultrasound
Longitudinal changes in muscle thickness measured by ultrasound from baseline to 1 year after kidney transplantation.
Measured: From baseline to 1 year after kidney transplantation
Change in Muscle Cross-Sectional Area Measured by Ultrasound
Longitudinal changes in muscle cross-sectional area measured by ultrasound from baseline to 1 year after kidney transplantation.
Measured: From baseline to 1 year after kidney transplantation
Change in Muscle Echogenicity Measured by Ultrasound
Longitudinal changes in muscle echogenicity measured by ultrasound from baseline to 1 year after kidney transplantation.
Measured: From baseline to 1 year after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607236
- Sponsor's protocol ID
- 2026-304
- Acronym
- KT-SARC
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to institutional policy and participant privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Multimodal Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07607236
- Acronym / sponsor ID
- KT-SARC / 2026-304
- Conditions
- Sarcopenia, Kidney Transplantation, Muscle Wasting
- Keywords
- Muscle Ultrasound, Bioelectrical Impedance Analysis, BIA-SMI, Kidney Transplant Recipient, Muscle Mass, Frailty, Prospective Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 26 May 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 prospective observational study designed to evaluate the effectiveness of multimodal muscle ultrasound for the assessment of sarcopenia in kidney transplant recipients. Adult patients undergoing kidney transplantation will undergo both muscle ultrasound and bioelectrical impedance analysis (BIA) at predefined time points before and after transplantation.
The primary objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment, including its correlation and agreement with BIA-derived skeletal muscle index (BIA-SMI), as well as its diagnostic accuracy. Secondary objectives include describing the longitudinal changes in sarcopenia prevalence and muscle-related parameters from the pre-transplant period to 1 year after transplantation.
The study aims to provide evidence for a convenient, noninvasive, radiation-free, and reliable method for sarcopenia assessment in kidney transplant recipients.
Detailed description
Sarcopenia is highly prevalent among patients with end-stage renal disease and is associated with poor clinical outcomes. Although kidney transplantation may improve overall health status, perioperative stress, immunosuppressive therapy, and postoperative metabolic changes may influence muscle mass and function. Reliable assessment of sarcopenia in kidney transplant recipients remains clinically important.
Current methods for sarcopenia assessment include computed tomography (CT), dual-energy X-ray absorptiometry (DXA), and bioelectrical impedance analysis (BIA). However, CT and DXA are limited by radiation exposure, cost, and accessibility, while BIA may be affected by changes in hydration status, especially in transplant recipients. Muscle ultrasound is a portable, radiation-free, and bedside-available imaging modality that may provide a practical alternative for muscle assessment.
This prospective observational study will enroll adult kidney transplant recipients at Sichuan Provincial People's Hospital. Participants will undergo multimodal muscle ultrasound and BIA examinations at predefined perioperative time points. Ultrasound parameters will include muscle thickness, cross-sectional area, and echogenicity.
The primary study objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard. Correlation analysis, intraclass correlation coefficients, Bland-Altman analysis, and receiver operating characteristic (ROC) curve analysis will be performed to evaluate agreement and diagnostic accuracy.
Secondary objectives include evaluating longitudinal changes in muscle-related parameters and sarcopenia prevalence from the pre-transplant period to 1 year after kidney transplantation. Linear mixed-effects models or generalized estimating equations will be used to analyze temporal trends.
This study aims to establish muscle ultrasound as a practical and reliable tool for sarcopenia assessment in kidney transplant recipients and to improve understanding of perioperative muscle changes after transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Recipients | – | Diagnostic Test: Muscle UltrasoundAdult kidney transplant recipients undergoing prospective assessment of sarcopenia using multimodal muscle ultrasound and bioelectrical impedance analysis (BIA). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney transplant recipients undergoing perioperative sarcopenia assessment at Sichuan Provincial People's Hospital.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Patients scheduled to undergo kidney transplantation
- Ability to undergo muscle ultrasound and bioelectrical impedance analysis (BIA)
- Ability to provide written informed consent
Key exclusion criteria (3 listed)
- Patients with severe limb deformity or conditions preventing muscle ultrasound assessment
- Patients with implanted electronic devices contraindicating BIA assessment
- Inability to complete study assessments
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 |
|---|---|---|
| Muscle UltrasoundMultimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients. | Diagnostic test | Kidney Transplant Recipients |
Primary outcome
Area under the receiver operating characteristic (ROC) curve of muscle ultrasound for detecting sarcopenia using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard.
Time frame: From baseline to 1 year after kidney transplantation
Diagnostic performance of multimodal muscle ultrasound for sarcopenia assessment using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard, including receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
3 secondary outcomes
Change in Muscle Thickness Measured by Ultrasound
Time frame: From baseline to 1 year after kidney transplantation
Change in Muscle Cross-Sectional Area Measured by Ultrasound
Time frame: From baseline to 1 year after kidney transplantation
Change in Muscle Echogenicity Measured by Ultrasound
Time frame: From baseline to 1 year after kidney transplantation
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 26 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to institutional policy and participant privacy considerations.
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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.
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 Sarcopenia and Kidney Transplantation, run by Sichuan Provincial People's 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 May 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?
Contact Yifu Hou, MD, PhD (+86-18980732072, houyifu0726@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic (ROC) curve of muscle ultrasound for detecting sarcopenia using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard. (time frame: From baseline to 1 year after kidney transplantation). 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 26 May 2026.