NephrologyNCT06441435
The Effect of AC-134 in Chronic Kidney Diseases
A study testing Low protein diet with AC-134 and Standard treatment in people with Nephrology, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Nephrology
- What is being tested?
- Low protein diet with AC-134 and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 5 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-90 years.
- Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.
- Signed informed consent is required before enrollment.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taichung Veterans General Hospital.
Taichung, ROC, 40705
Taichung Veterans General Hospital
Taichung, ROC, 40705
About this study
Official title: To Investigate the Protective 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.
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.
- Conditions
- Nephrology
- Being tested
- Low protein diet with AC-134, Standard treatment
- Keywords
- Chronic Kidney Diseases, Activated charcoal
- Medical subject headings
- Renal Insufficiency, Chronic, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low protein diet with AC-134Dietary supplement
Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day
Standard treatmentOther
Low protein diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Low-protein diet strategies combined with AC-134 capsules Receives: Dietary Supplement: Low protein diet with AC-134 |
| Control group | Active comparator | Low-protein diet strategies Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate (eGFR) measurement
The eGFR level is a maker for kidney function
Measured: Baseline to 3 months
Blood Urea Nitrogen (BUN) levels
Blood Urea Nitrogen
Measured: Baseline to 3 months
Uremic toxins assay
The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples
Measured: Baseline to 3 months
Secondary outcomes (14)
Liver function
The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples
Measured: Baseline to 3 months
Inflammation makers
The concentration of inflammation makers in the subjects' blood samples
Measured: Baseline to 3 months
Nutrition status
The concentration of albumin, wbc and uric acid in the subjects' blood samples
Measured: Baseline to 3 months
Lipid analysis
The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
Measured: Baseline to 3 months
Sugar test
The concentration of fasting sugar and HbA1C in the subjects' blood samples
Measured: Baseline to 3 months
The quality of life
It will measure by the Kidney Disease Quality of Life ([KDQOL]-SF™) questionnaire
Measured: Baseline to 3 months
Anemia test
The concentration of hemoglobin (Hb) in the subject's blood samples
Measured: Baseline to 3 months
Urine protein analysis
Urine specimen collection will be evaluated on the spot and 24-hour urine protein
Measured: Baseline to 3 months
24-hour Dietary recall
There will be collected by food models or a photography atlas to estimate portion size
Measured: Baseline to 3 months
Gastrointestinal symptoms measures
There will be collected by questionnaires symptoms or chief complaints
Measured: Baseline to 3 months
Grip strength levels
Hand grip strength was measured by grip strength device
Measured: Baseline to 3 months
Blood gas
The concentration of blood gas test in the subject's blood samples
Measured: Baseline to 3 months
Electrolytes Analysis
The concentration of electrolytes analysis in the subject's blood samples
Measured: Baseline to 3 months
Mitochondrial oxidative stress
The concentration analysis in the subject's blood or urine samples, such as MDA
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start5 Jun 2024
- Primary completion11 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrologyStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- All Clean Health Co., Ltd
- Responsible party
- Principal investigator, Cheng-Hsu Chen, Taichung Veterans General Hospital
- Investigators
- Cheng-Hsu Chen, MDPHD, Principal investigator, Division of Nephrology in Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441435
- Sponsor's protocol ID
- SF23520C
- Status last verified
- Jun 2026
- First submitted
- 21 May 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Protective Effect of AC 134 in Chronic Kidney Diseases.
- ClinicalTrials.gov ID
- NCT06441435
- Acronym / sponsor ID
- SF23520C
- Conditions
- Nephrology
- Keywords
- Chronic Kidney Diseases, Activated charcoal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- All Clean Health Co., Ltd
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Low protein diet with AC-134Low-protein diet strategies combined with AC-134 capsules |
| Control group | Active comparator | Other: Standard treatmentLow-protein diet strategies |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 20-90 years.
- Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.
- Signed informed consent is required before enrollment.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low protein diet with AC-134Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day | Dietary supplement | Intervention group |
| Standard treatmentLow protein diet | Other | Control group |
Primary outcome
Estimated glomerular filtration rate (eGFR) measurement
Time frame: Baseline to 3 months
The eGFR level is a maker for kidney function
Blood Urea Nitrogen (BUN) levels
Time frame: Baseline to 3 months
Blood Urea Nitrogen
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
14 secondary outcomes
Liver function
Time frame: Baseline to 3 months
Inflammation makers
Time frame: Baseline to 3 months
Nutrition status
Time frame: Baseline to 3 months
Lipid analysis
Time frame: Baseline to 3 months
Sugar test
Time frame: Baseline to 3 months
The quality of life
Time frame: Baseline to 3 months
Anemia test
Time frame: Baseline to 3 months
Urine protein analysis
Time frame: Baseline to 3 months
24-hour Dietary recall
Time frame: Baseline to 3 months
Gastrointestinal symptoms measures
Time frame: Baseline to 3 months
Grip strength levels
Time frame: Baseline to 3 months
Blood gas
Time frame: Baseline to 3 months
Electrolytes Analysis
Time frame: Baseline to 3 months
Mitochondrial oxidative stress
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Hsu Chen, MDPHD principal investigator
Division of Nephrology in Taichung Veterans General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low protein diet with AC-134 and Standard treatment in people with Nephrology, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated glomerular filtration rate (eGFR) measurement (time frame: Baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.