The objective is to explore the effects of adding AC-134 on renal function, proteinuria, uremic toxins, and metabolism-related markers in chronic kidney disease.
Chronic kidney disease (CKD) management primarily focuses on addressing associated complications such as hypertension, diabetes mellitus, cardiovascular disease, and proteinuria. In addition to standard therapies, reducing the accumulation of toxins, particularly gut-derived uremic toxins like indoxyl sulfate (IS) and p-cresol sulfate (PCS), may help alleviate uremia symptoms. This study assesses the impact of oral AC-134 capsules containing activated charcoal adsorbent on CKD patients. The assessment will include evaluating changes in renal function, proteinuria, uremic toxins, and metabolism-related markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day
Low protein diet
Taichung Veterans General Hospital
Taichung, ROC, Taiwan
Estimated glomerular filtration rate (eGFR) measurement
The eGFR level is a maker for kidney function
Time frame: Baseline to 3 months
Blood Urea Nitrogen (BUN) levels
Blood Urea Nitrogen
Time frame: Baseline to 3 months
Uremic toxins assay
The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples
Time frame: Baseline to 3 months
Liver function
The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples
Time frame: Baseline to 3 months
Inflammation makers
The concentration of inflammation makers in the subjects' blood samples
Time frame: Baseline to 3 months
Nutrition status
The concentration of albumin, wbc and uric acid in the subjects' blood samples
Time frame: Baseline to 3 months
Lipid analysis
The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
Time frame: Baseline to 3 months
Sugar test
The concentration of fasting sugar and HbA1C in the subjects' blood samples
Time frame: Baseline to 3 months
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The quality of life
It will measure by the Kidney Disease Quality of Life (\[KDQOL\]-SF™) questionnaire
Time frame: Baseline to 3 months
Anemia test
The concentration of hemoglobin (Hb) in the subject's blood samples
Time frame: Baseline to 3 months
Urine protein analysis
Urine specimen collection will be evaluated on the spot and 24-hour urine protein
Time frame: Baseline to 3 months
24-hour Dietary recall
There will be collected by food models or a photography atlas to estimate portion size
Time frame: Baseline to 3 months
Gastrointestinal symptoms measures
There will be collected by questionnaires symptoms or chief complaints
Time frame: Baseline to 3 months
Grip strength levels
Hand grip strength was measured by grip strength device
Time frame: Baseline to 3 months
Blood gas
The concentration of blood gas test in the subject's blood samples
Time frame: Baseline to 3 months
Electrolytes Analysis
The concentration of electrolytes analysis in the subject's blood samples
Time frame: Baseline to 3 months
Mitochondrial oxidative stress
The concentration analysis in the subject's blood or urine samples, such as MDA
Time frame: Baseline to 3 months