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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
Sponsor:
Information provided by (Responsible Party):
Jun Chul Kim, Gumi Cha Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Renamezin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Renamezin (AST-120) group or non-Renamezin group
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Renamezin
oral treatment duration: three times a day, 7 capsules (2g) once, for 48 weeks
Drug: Renamezin
7 capsules once, three times a day, for 48 weeks
Other Name: Renamezin administration

No Intervention: Non-Renamezin
no use of Renamezin



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Body composition test [ Time Frame: Baseline, 24 week, 48 week ]
    Bioelectrical impedance analysis (using InBody S10)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Death rate [ Time Frame: Through study completion, an average of 2 years ]
    Death rate is calculated if any patients expire during participation.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult older than 19 years
  • Pre-dialysis chronic kidney disease
  • Serum creatinine level 2.0-5.0 mg/dL or MDRD or CKD-EPI eGFR 15-60 mL/min/1.73 m²
  • Serum albumin ≥ 3.0 g/dL
  • No previous use of oral absorbant during 4 weeks prior to screening
  • No change of treatment for chronic kidney disease during 4 weeks prior to screening
  • Written informed consent to participate in this clinical study
  • Capable of independent physical activity, an assisted device use is acceptable

Exclusion Criteria:

  • Impaired GI peristalsis
  • Uncontrolled constipation
  • Prior renal transplant
  • On immunosuppressant (small dose users may be accepted according to the PI's decision)
  • GI ulcer or esophageal varix
  • Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg)
  • History of admission for an acute cardiovascular incident within 3 months prior to screening
  • Current acute infection state
  • Liver function failure (ALT, AST over 2.5 times of normal reference range)
  • Uncontrolled diabetes patient (HbA1c >10 % or fasting glucose >250 mg/dL)
  • Malignancy (patients of post-remission 5 years without any recurrence can be enrolled, except for squamous cell carcinoma in situ)
  • Pregnancy, on breastfeeding
  • Not agreed to medical contraceptive use during participating in the study
  • Concurrent participation in another clinical trial
  • Drug or alcohol-dependent
  • Other clinical trial medication administration more than once within 30 days prior to enrollment
  • Expected dialysis or kidney transplantation within 3 months prior to enrollment
  • Dependent physical activity
  • Musculoskeletal disease that may debilitate functional independence
  • Lower limb amputee not using a prosthesis
  • Severe retinal disease (e.g., proliferative diabetic retinopathy, vitreous hemorrhage)
  • Claudication
  • Other patients inappropriate to participate by the PI's decision

Information from the National Library of Medicine

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


Contacts
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Contact: Ji-Hyung Cho, MD 82-54-450-9556 tigerpyramid@hanmail.net

Locations
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Korea, Republic of
CHA Gumi Medical Center Recruiting
Gumi, Gyeongsangbuk-do, Korea, Republic of, 39295
Contact: Ji-Hyung Cho, MD         
Sponsors and Collaborators
Gumi Cha Medical Center
Investigators
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Principal Investigator: Jun Chul Kim, MD, PhD CHA Gumi Medical Center

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Responsible Party: Jun Chul Kim, Professor, Gumi Cha Medical Center
ClinicalTrials.gov Identifier: NCT03788252     History of Changes
Other Study ID Numbers: GM18-11
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Chul Kim, Gumi Cha Medical Center:
Sarcopenia
AST-120
Indoxyl sulfate
Additional relevant MeSH terms:
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Sarcopenia
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms