ClinicalTrials.gg
CompletedNCT06441435Updated Jun 12, 2026

The Effect of AC-134 in Chronic Kidney Diseases

An interventional study of Low protein diet with AC-134 and Standard treatment in Nephrology, sponsored by Taichung Veterans General Hospital. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Taichung Veterans General Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Nephrology

Keywords

  • Chronic Kidney Diseases
  • Activated charcoal
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's enrollment of 100 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Intervention group

    Low-protein diet strategies combined with AC-134 capsules

    Dietary Supplement: Low protein diet with AC-134

  • Active comparator
    Control group

    Low-protein diet strategies

    Other: Standard treatment

Interventions

  • Dietary supplementLow protein diet with AC-134

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

  • OtherStandard treatment

    Low protein diet

06

What researchers measure

Primary outcomes

  1. Estimated glomerular filtration rate (eGFR) measurement

    The eGFR level is a maker for kidney function

    Time frame: Baseline to 3 months

  2. Blood Urea Nitrogen (BUN) levels

    Blood Urea Nitrogen

    Time frame: Baseline to 3 months

  3. 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

Secondary outcomes

  1. Liver function

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

    Time frame: Baseline to 3 months

  2. Inflammation makers

    The concentration of inflammation makers in the subjects' blood samples

    Time frame: Baseline to 3 months

  3. Nutrition status

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

    Time frame: Baseline to 3 months

  4. Lipid analysis

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

    Time frame: Baseline to 3 months

  5. Sugar test

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

    Time frame: Baseline to 3 months

  6. The quality of life

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

    Time frame: Baseline to 3 months

  7. Anemia test

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

    Time frame: Baseline to 3 months

  8. Urine protein analysis

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

    Time frame: Baseline to 3 months

  9. 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

  10. Gastrointestinal symptoms measures

    There will be collected by questionnaires symptoms or chief complaints

    Time frame: Baseline to 3 months

  11. Grip strength levels

    Hand grip strength was measured by grip strength device

    Time frame: Baseline to 3 months

  12. Blood gas

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

    Time frame: Baseline to 3 months

  13. Electrolytes Analysis

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

    Time frame: Baseline to 3 months

  14. Mitochondrial oxidative stress

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

    Time frame: Baseline to 3 months

07

Study locations

2 sites
  • Taichung Veterans General Hospital.
    Taichung, ROC 40705, Taiwan
  • Taichung Veterans General Hospital
    Taichung, ROC 40705, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06441435
Collaborators
All Clean Health Co., Ltd
Responsible party
Cheng-Hsu Chen (Professor, Division Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung Veterans General Hospital) — Principal investigator
First posted
Jun 4, 2024
Start date
Jun 5, 2024
Primary completion
Jun 11, 2025
Completion
Jun 30, 2025
Last update
Jun 12, 2026

Study contacts

Cheng-Hsu Chen, MDPHD
principal investigator · Division of Nephrology in Taichung Veterans General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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