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NCT Number: NCT05353660

Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 1.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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. sarcopenia

    Time frame: 1 year

    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

  2. The progression of chronic kidney diseases in CKD patients

    Time frame: 1 year

    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)

  3. All-cause mortality in maintenance hemodialysis patients

    Time frame: 1 year

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

Secondary outcomes

  1. CVD mortality

    Time frame: 1 year

    CVD mortality included cerebrovascular accidents, heart failure, myocardial infarction, cardiac arrest, death caused by malignant arrhythmias, and sudden death.

  2. cardiovascular events

    Time frame: 1 year

    Cardiovascular events included stroke, myocardial infarction, angina, congestive heart failure and other cardiovascular events.

  3. Rate of participants with hospitalization.

    Time frame: 1 year

    Hospitalization for any reason

  4. Rate of participants with fall.

    Time frame: 1 year

    Rate of participants with fall.

  5. Rate of participants with bone fracture.

    Time frame: 1 year

    Rate of participants with bone fracture.

  6. Change of quality of life

    Time frame: 1 year

    The quality of life is assessd by 12-item Short-Form Health Survey Questionnaire (SF-12) Survey Questionnaire (SF-12)

  7. Frailty

    Time frame: 1 year

    Frailty is assessed by The FRAIL Scale. The FRAIL Scale consists of five items: fatigue, resistance, ambulation, illness, and loss of weight. The scores range from 0 to 5,with 3 to 5 as frail, 1 to 2 as pre-frail, and 0 as normal.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Liang, MD

CONTACT

[email protected]

+86-20-61686217

Yaya Yang

CONTACT

[email protected]

+86-20-62786327

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Risk Factors of Chronic Kidney Disease-related Sarcopenia and Its Relationship With Poor Prognosis

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2022
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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