Role of AST120 for Sarcopenia Prevention in Pre-dialysis Chronic Kidney Disease (RECOVERY)
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|ClinicalTrials.gov Identifier: NCT03788252|
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases||Drug: Renamezin||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Renamezin (AST-120) group or non-Renamezin group|
|Masking:||None (Open Label)|
|Official Title:||RolE of AST120 in sarCOpenia preVEntion in pRe-dialYsis Chronic Kidney Disease Patients (RECOVERY): Prospective Open-label Randomized Controlled Multicenter Study|
|Actual Study Start Date :||November 23, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Renamezin
oral treatment duration: three times a day, 7 capsules (2g) once, for 48 weeks
7 capsules once, three times a day, for 48 weeks
Other Name: Renamezin administration
No Intervention: Non-Renamezin
no use of Renamezin
- Change of 6 meter walking speed at 24 weeks [ Time Frame: Change of baseline 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.
- Change of 6 meter walking speed at 48 weeks [ Time Frame: Change of baseline 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.
- Body composition test [ Time Frame: Baseline, 24 week, 48 week ]Bioelectrical impedance analysis (using InBody S10)
- Serum level of indoxyl sulfate, myostatin, Tumor Necrosis Factor-alpha, Interleukin-6 [ Time Frame: Baseline, 24 week, 48 week ]Level of serum indoxyl sulfate, myostatin, TNF-alpha, and IL-6 will be obtained by laboratory blood test.
- Serum level of creatinine and estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, 24 week, 48 week ]Level of serum creatinine, and eGFR (mL/min/1.73 m²) will be obtained by laboratory blood test.
- Kidney Disease Quality of Life Short Form 1.3 (KDQOL-SF 1.3) [ Time Frame: Baseline, 24 week, 48 week ]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.
- Charlson Co-morbidity Index [ Time Frame: Baseline, 24 week, 48 week ]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.
- International Physical Activity Questionnaire Short Form [ Time Frame: Baseline, 24 week, 48 week ]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.
- Grip strength [ Time Frame: Baseline, 24 week, 48 week ]Using TAKEI handgrip strength dynamometer (TKK5401, Japan), grip strength while flexing elbow and extending elbow will be assessed.
- 24h body activity measure [ Time Frame: Baseline, 24 week, 48 week ]Using BAND2 model of InBody cooperation, activity amount of each participant is collected for 7 days.
- Time of dialysis initiation [ Time Frame: Through study completion, an average of 2 years ]If a patient requires dialysis initiation during study period, the date is recorded.
- Rate of hospital admission [ Time Frame: Through study completion, an average of 2 years ]The rate of patients requiring in-patient care during the study participation is calculated.
- Death rate [ Time Frame: Through study completion, an average of 2 years ]Death rate is calculated if any patients expire during participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788252
|Contact: Ji-Hyung Cho, MDfirstname.lastname@example.org|
|Korea, Republic of|
|CHA Gumi Medical Center||Recruiting|
|Gumi, Gyeongsangbuk-do, Korea, Republic of, 39295|
|Contact: Ji-Hyung Cho, MD|
|Principal Investigator:||Jun Chul Kim, MD, PhD||CHA Gumi Medical Center|