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Clinical Trial Details

Trial ID: L0043
Source ID: NCT03788252
Associated Drug: Renamezin
Title: Role of AST120 for Sarcopenia Prevention in Pre-dialysis Chronic Kidney Disease
Acronym: RECOVERY
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Renamezin
Outcome Measures: Primary: 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., 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., Change of baseline 6 meter walking speed at 48 weeks | Secondary: Body composition test, Bioelectrical impedance analysis (using InBody S10), 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., 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., 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., Baseline, 24 week, 48 week|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., 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., 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., 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., Baseline, 24 week, 48 week | Other: Time of dialysis initiation, If a patient requires dialysis initiation during study period, the date is recorded., Through study completion, an average of 2 years|Rate of hospital admission, The rate of patients requiring in-patient care during the study participation is calculated., Through study completion, an average of 2 years|Death rate, Death rate is calculated if any patients expire during participation., Through study completion, an average of 2 years
Sponsor/Collaborators: Sponsor: Gumi Cha Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2018-11-23
Completion Date: 2020-07-14
Results First Posted:
Last Update Posted: 2020-12-17
Locations: CHA Gumi Medical Center, Gumi, Gyeongsangbuk-do, 39295, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03788252