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

NCT03788252 | Completed Phase 4

• 1 other identifier: GM18-11
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

Sarcopenia; AST-120; Indoxyl sulfate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Body composition test

  Baseline, 24 week, 48 week

• Serum level of indoxyl sulfate, myostatin, Tumor Necrosis Factor-alpha, Interleukin-6

  Baseline, 24 week, 48 week

• Serum level of creatinine and estimated Glomerular Filtration Rate (eGFR)

  Baseline, 24 week, 48 week

• Kidney Disease Quality of Life Short Form 1.3 (KDQOL-SF 1.3)

  Baseline, 24 week, 48 week

• Charlson Co-morbidity Index

  Baseline, 24 week, 48 week

Other Outcomes (3)

• Time of dialysis initiation

  Through study completion, an average of 2 years

• Rate of hospital admission

  Through study completion, an average of 2 years

• Death rate

  Through study completion, an average of 2 years

Study Arms (2)

Renamezin

ACTIVE COMPARATOR

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

Drug: Renamezin

Non-Renamezin

NO INTERVENTION

no use of Renamezin

Interventions

Renamezin DRUG

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

Also known as: Renamezin administration

Renamezin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gumi Cha Medical Center: lead

Study Sites (1)

CHA Gumi Medical Center

Gumi, Gyeongsangbuk-do, 39295, South Korea

Location

Related Publications (3)

• 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.

  PMID: 36287929 DERIVED

• 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.

  PMID: 35963741 DERIVED

• 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.

  PMID: 34862753 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sarcopenia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Jun Chul Kim, MD, PhD

  CHA Gumi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Renamezin (AST-120) group or non-Renamezin group

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 27, 2018
• Study Start: November 23, 2018
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

KR (1)