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Chronic Kidney DiseasesPhase 4RECOVERYNCT03788252

Role of AST120 for Sarcopenia Prevention in Pre-dialysis Chronic Kidney Disease

A Phase 4 study testing Renamezin in people with Chronic Kidney Diseases, run by Gumi Cha Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Renamezin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSouth Korea
Study dates
23 Nov 2018to 14 Jul 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Gumi Medical Center

    Gumi, Gyeongsangbuk-do, 39295

Other trials in South Korea

About this study

Official title: RolE of AST120 in sarCOpenia preVEntion in pRe-dialYsis Chronic Kidney Disease Patients (RECOVERY): Prospective Open-label Randomized Controlled Multicenter Study

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.

Read the 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.

Being tested
Renamezin
Keywords
Sarcopenia, AST-120, Indoxyl sulfate
Medical subject headings
Renal Insufficiency, Chronic, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RenamezinDrug

    Also called Renamezin administration

    7 capsules once, three times a day, for 48 weeks

Study groups in NCT03788252
Study groupRoleWhat they receive
RenamezinActive comparatororal treatment duration: three times a day, 7 capsules (2g) once, for 48 weeks
Receives: Drug: Renamezin
Non-RenamezinNo interventionno use of Renamezin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change of baseline 6 meter walking speed at 24 weeks

  2. 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.

    Measured: Change of baseline 6 meter walking speed at 48 weeks

Secondary outcomes (8)

  1. Body composition test

    Bioelectrical impedance analysis (using InBody S10)

    Measured: Baseline, 24 week, 48 week

  2. 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.

    Measured: Baseline, 24 week, 48 week

  3. 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.

    Measured: Baseline, 24 week, 48 week

  4. 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.

    Measured: Baseline, 24 week, 48 week

  5. 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.

    Measured: Baseline, 24 week, 48 week

  6. 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.

    Measured: Baseline, 24 week, 48 week

  7. Grip strength

    Using TAKEI handgrip strength dynamometer (TKK5401, Japan), grip strength while flexing elbow and extending elbow will be assessed.

    Measured: Baseline, 24 week, 48 week

  8. 24h body activity measure

    Using BAND2 model of InBody cooperation, activity amount of each participant is collected for 7 days.

    Measured: Baseline, 24 week, 48 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2018
  2. Study start23 Nov 2018
  3. Primary completion14 Jul 2020
  4. Study completion14 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Renamezin (AST-120) group or non-Renamezin group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03788252
Sponsor's protocol ID
GM18-11
Acronym
RECOVERY
Status last verified
Dec 2020
First submitted
28 Nov 2018
Last updated
17 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee SM, Han MY, Kim SH, Cha RH, Kang SH, Kim JC, An WS. Indoxyl Sulfate Might Play a Role in Sarcopenia, While Myostatin Is an Indicator of Muscle Mass in Patients with Chronic Kidney Disease: Analysis from the RECOVERY Study. Toxins (Basel). 2022 Sep 23;14(10):660. doi: 10.3390/toxins14100660.

    PubMed 36287929

  • Shin J, Kim JC, Kim SH. Reply - Letter to the editor: Comment on "phase angle as a marker for muscle health and quality of life in patients with chronic kidney disease". Clin Nutr. 2022 Sep;41(9):2058. doi: 10.1016/j.clnu.2022.07.020. Epub 2022 Jul 21. No abstract available.

    PubMed 35963741

  • Cha RH, Kang SH, Han MY, An WS, Kim SH, Kim JC. Effects of AST-120 on muscle health and quality of life in chronic kidney disease patients: results of RECOVERY study. J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):397-408. doi: 10.1002/jcsm.12874. Epub 2021 Dec 3.

    PubMed 34862753

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Renamezin in people with Chronic Kidney Diseases, run by Gumi Cha Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of 6 meter walking speed at 24 weeks (time frame: Change of baseline 6 meter walking speed at 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03788252, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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