This study is to assess the effect of 48 weeks administration of Renamezin capsule on prevention of sarcopenia in pre-dialysis patients with chronic kidney disease.
Skeletal muscle atrophy, referred to as sarcopenia, and impaired physical performance are accompanied in chronic kidney disease patients during disease progression. Decreased physical performance derived from sarcopenia precipitates poor prognostic influence in the clinical outcome, as reported in previous studies showing correlations between poor physical performance, poor quality of life, poor renal prognosis, and mortality. Therefore, maintaining physical performance is mandatory to improve the prognosis of chronic kidney disease patients. AST-120 is an oral absorbent capsule designed to remove circulating indoxyl sulfate, a uremic toxin. As indoxyl sulfate is reported to cause mitochondrial dysfunction in skeletal muscle, AST-120 contributes to the recovery of mitochondrial function by reducing indoxyl sulfate. In addition, AST-120 is reported to delay the initiation of dialysis and the decrease of glomerular filtration rate and the increase of serum creatinine level. However, the effect of AST-120 on sarcopenia in pre-dialysis patients have not been reported. This study is to investigate the effect of AST-120 on sarcopenia prevention in pre-dialysis chronic kidney disease patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
7 capsules once, three times a day, for 48 weeks
CHA Gumi Medical Center
Gumi, Gyeongsangbuk-do, South Korea
Change of 6 meter walking speed at 24 weeks
As a measure of physical performance, 6 meter walking test is used. Static start and dynamic start speed will be assessed twice each.
Time frame: Change of baseline 6 meter walking speed at 24 weeks
Change of 6 meter walking speed at 48 weeks
As a measure of physical performance, 6 meter walking test is used. Static start and dynamic start speed will be assessed twice each.
Time frame: Change of baseline 6 meter walking speed at 48 weeks
Body composition test
Bioelectrical impedance analysis (using InBody S10)
Time frame: Baseline, 24 week, 48 week
Serum level of indoxyl sulfate, myostatin, Tumor Necrosis Factor-alpha, Interleukin-6
Level of serum indoxyl sulfate, myostatin, TNF-alpha, and IL-6 will be obtained by laboratory blood test.
Time frame: Baseline, 24 week, 48 week
Serum level of creatinine and estimated Glomerular Filtration Rate (eGFR)
Level of serum creatinine, and eGFR (mL/min/1.73 m²) will be obtained by laboratory blood test.
Time frame: Baseline, 24 week, 48 week
Kidney Disease Quality of Life Short Form 1.3 (KDQOL-SF 1.3)
Health-related quality of life (HRQOL) is assessed via KDQOL-SF 1.3. KDQOL-SF 1.3 is validated questionnaires to assess HRQOL. HRQOL consists of three subscales; physical health, mental health, and kidney disease health. The summation of subscales ranges between 0 - 100, and the higher values indicate the better HRQOL status.
Time frame: Baseline, 24 week, 48 week
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Charlson Co-morbidity Index
Charlson Co-morbidity Index is used to assess underlying co-morbidity of each patient. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Age weighting is added to total comorbidity score in a score of zero to four.
Time frame: Baseline, 24 week, 48 week
International Physical Activity Questionnaire Short Form
International Physical Activity Questionnaire (IPAQ) Short Form is used to assess the amount of time spent for daily physical activity. IPAQ Short Form comprises of 7 questionnaires of activities which asks to report time spent for each activity during last week.
Time frame: Baseline, 24 week, 48 week
Grip strength
Using TAKEI handgrip strength dynamometer (TKK5401, Japan), grip strength while flexing elbow and extending elbow will be assessed.
Time frame: Baseline, 24 week, 48 week
24h body activity measure
Using BAND2 model of InBody cooperation, activity amount of each participant is collected for 7 days.
Time frame: Baseline, 24 week, 48 week