RolE of AST120 in sarCOpenia preVEntion in pRe-dialYsis Chronic Kidney Disease Patients (RECOVERY): Prospective Open-label Randomized Controlled Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of 6 meter walking speed at 24 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Renamezin
oral treatment duration: three times a day, 7 capsules (2g) once, for 48 weeks
干预措施: Renamezin (Drug)
结局指标
主要结局
Change of 6 meter walking speed at 24 weeks
时间窗: 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.
Change of 6 meter walking speed at 48 weeks
时间窗: 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.
次要结局
- Serum level of creatinine and estimated Glomerular Filtration Rate (eGFR)(Baseline, 24 week, 48 week)
- Body composition test(Baseline, 24 week, 48 week)
- International Physical Activity Questionnaire Short Form(Baseline, 24 week, 48 week)
- Grip strength(Baseline, 24 week, 48 week)
- Serum level of indoxyl sulfate, myostatin, Tumor Necrosis Factor-alpha, Interleukin-6(Baseline, 24 week, 48 week)
- 24h body activity measure(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)
研究者
Jun Chul Kim
Professor
Gumi Cha Medical Center