The Effect of AC-134 in Chronic Kidney Diseases

June 10, 2026 updated by: Cheng-Hsu Chen, Taichung Veterans General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • ROC
      • Taichung, ROC, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, ROC, Taiwan, 40705
        • Taichung Veterans General Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Low-protein diet strategies combined with AC-134 capsules
Dietary supplement: Low protein diet with AC-134
Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day
Active Comparator: Control group
Low-protein diet strategies
Other: Standard treatment
Low protein diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Estimated glomerular filtration rate (eGFR) measurement
Time Frame: Baseline to 3 months
The eGFR level is a maker for kidney function
Baseline to 3 months
Blood Urea Nitrogen (BUN) levels
Time Frame: Baseline to 3 months
Blood Urea Nitrogen
Baseline to 3 months
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
Baseline to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liver function
Time Frame: Baseline to 3 months
The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples
Baseline to 3 months
Inflammation makers
Time Frame: Baseline to 3 months
The concentration of inflammation makers in the subjects' blood samples
Baseline to 3 months
Nutrition status
Time Frame: Baseline to 3 months
The concentration of albumin, wbc and uric acid in the subjects' blood samples
Baseline to 3 months
Lipid analysis
Time Frame: Baseline to 3 months
The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
Baseline to 3 months
Sugar test
Time Frame: Baseline to 3 months
The concentration of fasting sugar and HbA1C in the subjects' blood samples
Baseline to 3 months
The quality of life
Time Frame: Baseline to 3 months
It will measure by the Kidney Disease Quality of Life ([KDQOL]-SF™) questionnaire
Baseline to 3 months
Anemia test
Time Frame: Baseline to 3 months
The concentration of hemoglobin (Hb) in the subject's blood samples
Baseline to 3 months
Urine protein analysis
Time Frame: Baseline to 3 months
Urine specimen collection will be evaluated on the spot and 24-hour urine protein
Baseline to 3 months
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
Baseline to 3 months
Gastrointestinal symptoms measures
Time Frame: Baseline to 3 months
There will be collected by questionnaires symptoms or chief complaints
Baseline to 3 months
Grip strength levels
Time Frame: Baseline to 3 months
Hand grip strength was measured by grip strength device
Baseline to 3 months
Blood gas
Time Frame: Baseline to 3 months
The concentration of blood gas test in the subject's blood samples
Baseline to 3 months
Electrolytes Analysis
Time Frame: Baseline to 3 months
The concentration of electrolytes analysis in the subject's blood samples
Baseline to 3 months
Mitochondrial oxidative stress
Time Frame: Baseline to 3 months
The concentration analysis in the subject's blood or urine samples, such as MDA
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taichung Veterans General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
All Clean Health Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheng-Hsu Chen, MDPHD, Division of Nephrology in Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SF23520C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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