NCT05353660

Brief Summary

Chronic kidney disease (CKD) has become a global public health priority over the past few decades, affecting 10-12% of the adult population and has received increasing attention. Sarcopenia describes a generalizes degenerative skeletal muscle disorder involving the loss of muscle mass, muscle function and/or physical performance. Indeed, Sarcopenia is a condition with many causes and it can be considered "primary sarcopenia" when no other cause is evident but ageing. While in the clinical practice, it also occurs in patients with chronic diseases, such as chronic kidney disease, which can be considered "secondary sarcopenia". Notably, the occurrence of sarcopenia in CKD patients is not only related with ageing, the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and oxidative stress also contribute to the muscle depletion. Moreover, sarcopenia increased risk of falls and fractures, impaired ability to perform activities of daily living, disabilities, loss of independence and increased risk of death. Hence, it is of great significance to prevent the occurrence and development of sarcopenia in patients with CKD. The purposes of this project were to investigate the prevalence of sarcopenia, further explore the risk factors for sarcopenia and detect the relationship between sarcopenia and outcomes in CKD patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Apr 2022Dec 2027

Study Start

First participant enrolled

April 11, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

April 25, 2022

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • sarcopenia

    The sarcopenia is defined as: Patients with low strength: handgrip \<28kg for male or \<18kg for female; Or low muscle mass: appendicular skeletal muscle mass/height2 \<7kg/m2 for male or \<5.7kg/m2 for female; Or low performance: 6-metre walk: \<1.0 m/s or 5-time chair stand test: ≥12 s

    1 year

  • The progression of chronic kidney diseases in CKD patients

    The progression of chronic kidney disease is defined as: Patients had a 50% or greater decrease in baseline eGFR \<60 ml /min/1.73m2; Or end-stage renal disease (eGFR \<15 ml /min/1.73m2, or initiation of renal replacement therapy)

    1 year

  • All-cause mortality in maintenance hemodialysis patients

    All-cause mortality is defined as the death due to any reasons.

    1 year

Secondary Outcomes (7)

  • CVD mortality

    1 year

  • cardiovascular events

    1 year

  • Rate of participants with hospitalization.

    1 year

  • Rate of participants with fall.

    1 year

  • Rate of participants with bone fracture.

    1 year

  • +2 more secondary outcomes

Study Arms (2)

chronic kidney disease

Other: No intervention

maintenance hemodialysis

Other: No intervention

Interventions

No intervention

chronic kidney diseasemaintenance hemodialysis

Eligibility Criteria

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

The participants will be recruited from department of Nephrology, Nanfang Hospital

You may qualify if:

  • aged ≥18 years and \<80 years 2.eGFR\<60ml/min/1.73m2 or had received maintenance dialysis for at least 3 months.

You may not qualify if:

  • Patients with neuromuscular diseases: such as muscular dystrophy, amyotrophic lateral sclerosis, spinal cord injury, stroke, and myasthenia gravis; 2.Patients with neurodegenerative diseases: such as Alzheimer's disease, Parkinson's disease and Huntington's disease; 3.patients with advanced malignant tumors; 4.Patients with acute infectious diseases in the past 3 months; 5. Patients with serious cardiovascular or cerebrovascular disease; 6.Moderate to severe edema; 7.Patients with rheumatoid arthritis, multiple sclerosis, or acute gout that limit joint mobility; 8.Pregnant ; 9.Patients identified to be unsuitable for enrollment by the study physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicSarcopenia

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

April 11, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The data will be available from the corresponding author upon request, after the request is submitted and formally reviewed and approved by the Ethics Committee of Nanfang Hospital.

Locations