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

Gumi Cha Medical Center

Status and phase

Completed

Phase 4

Conditions

Chronic Kidney Diseases

Treatments

Drug: Renamezin

Study type

Interventional

Funder types

Other

Identifiers

NCT03788252

GM18-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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