Status:
COMPLETED
Role of AST120 for Sarcopenia Prevention in Pre-dialysis Chronic Kidney Disease
Lead Sponsor:
Gumi Cha Medical Center
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 deri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03788252
Start Date
November 23 2018
End Date
July 14 2020
Last Update
December 17 2020
Active Locations (1)
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1
CHA Gumi Medical Center
Gumi, Gyeongsangbuk-do, South Korea, 39295