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

NCT ID: NCT03788252

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-23
• Study Completion Date: 2020-07-14

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.

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.

Conditions

Chronic Kidney Diseases

Keywords

Sarcopenia; AST-120; Indoxyl sulfate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Renamezin

oral treatment duration: three times a day, 7 capsules (2g) once, for 48 weeks

Group Type: ACTIVE_COMPARATOR

Renamezin

Intervention Type: DRUG

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

Non-Renamezin

no use of Renamezin

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Renamezin

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

Intervention Type: DRUG

Other Intervention Names

Renamezin administration

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gumi Cha Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jun Chul Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Chul Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHA Gumi Medical Center

Locations

CHA Gumi Medical Center

Gumi, Gyeongsangbuk-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 36287929 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35963741 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34862753 (View on PubMed)

Other Identifiers

GM18-11

Identifier Type: -

Identifier Source: org_study_id