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Completed

NCT Number: NCT06441435

The Effect of AC-134 in Chronic Kidney Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 20-90 years.
  • Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.
  • Signed informed consent is required before enrollment.

Exclusion criteria

  • Use of other brand-activated charcoal supplements during the study period.
  • Pregnant or lactating women.
  • Patients who have undergone kidney transplantation.
  • Obstructive nephropathy within the past month.
  • Acute kidney injury within the past three months.
  • Gastrointestinal bleeding or severe constipation within the past three months.
  • Patients with active malignancy within the past two years.
  • Severe cardiovascular diseases such as congestive heart failure New York class III-IV or cerebrovascular disease
  • Severe liver disease, such as liver cirrhosis with ascites.
  • Active infectious disease

Treatment and study plan

Low protein diet with AC-134

Dietary Supplement

Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day

standard treatment

Other

Low protein diet

Primary outcomes

  1. Estimated glomerular filtration rate (eGFR) measurement

    Time frame: Baseline to 3 months

    The eGFR level is a maker for kidney function

  2. Blood Urea Nitrogen (BUN) levels

    Time frame: Baseline to 3 months

    Blood Urea Nitrogen

  3. Uremic toxins assay

    Time frame: Baseline to 3 months

    The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples

Secondary outcomes

  1. Liver function

    Time frame: Baseline to 3 months

    The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples

  2. Inflammation makers

    Time frame: Baseline to 3 months

    The concentration of inflammation makers in the subjects' blood samples

  3. Nutrition status

    Time frame: Baseline to 3 months

    The concentration of albumin, wbc and uric acid in the subjects' blood samples

  4. Lipid analysis

    Time frame: Baseline to 3 months

    The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples

  5. Sugar test

    Time frame: Baseline to 3 months

    The concentration of fasting sugar and HbA1C in the subjects' blood samples

  6. The quality of life

    Time frame: Baseline to 3 months

    It will measure by the Kidney Disease Quality of Life ([KDQOL]-SF™) questionnaire

  7. Anemia test

    Time frame: Baseline to 3 months

    The concentration of hemoglobin (Hb) in the subject's blood samples

  8. Urine protein analysis

    Time frame: Baseline to 3 months

    Urine specimen collection will be evaluated on the spot and 24-hour urine protein

  9. 24-hour Dietary recall

    Time frame: Baseline to 3 months

    There will be collected by food models or a photography atlas to estimate portion size

  10. Gastrointestinal symptoms measures

    Time frame: Baseline to 3 months

    There will be collected by questionnaires symptoms or chief complaints

  11. Grip strength levels

    Time frame: Baseline to 3 months

    Hand grip strength was measured by grip strength device

  12. Blood gas

    Time frame: Baseline to 3 months

    The concentration of blood gas test in the subject's blood samples

  13. Electrolytes Analysis

    Time frame: Baseline to 3 months

    The concentration of electrolytes analysis in the subject's blood samples

  14. Mitochondrial oxidative stress

    Time frame: Baseline to 3 months

    The concentration analysis in the subject's blood or urine samples, such as MDA

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Collaborators

  • All Clean Health Co., Ltd

Registry information

Official study title

To Investigate the Protective Effect of AC 134 in Chronic Kidney Diseases.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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