NCT07607236

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jan 2028

First Submitted

Initial submission to the registry

May 11, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 11, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Muscle UltrasoundBioelectrical Impedance AnalysisBIA-SMIKidney Transplant RecipientMuscle MassFrailtyProspective Cohort

Outcome Measures

Primary Outcomes (1)

  • 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).

    From baseline to 1 year after kidney transplantation

Secondary Outcomes (3)

  • Change in Muscle Thickness Measured by Ultrasound

    From baseline to 1 year after kidney transplantation

  • Change in Muscle Cross-Sectional Area Measured by Ultrasound

    From baseline to 1 year after kidney transplantation

  • Change in Muscle Echogenicity Measured by Ultrasound

    From baseline to 1 year after kidney transplantation

Study Arms (1)

Kidney Transplant Recipients

Adult kidney transplant recipients undergoing prospective assessment of sarcopenia using multimodal muscle ultrasound and bioelectrical impedance analysis (BIA).

Diagnostic Test: Muscle Ultrasound

Interventions

Muscle UltrasoundDIAGNOSTIC_TEST

Multimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients.

Kidney Transplant Recipients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult kidney transplant recipients undergoing perioperative sarcopenia assessment at Sichuan Provincial People's Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with severe limb deformity or conditions preventing muscle ultrasound assessment
  • Patients with implanted electronic devices contraindicating BIA assessment
  • Inability to complete study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

SarcopeniaMuscular AtrophyFrailty

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 26, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly available due to institutional policy and participant privacy considerations.

Locations