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

• Status: Completed
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gumi Cha Medical Center

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