The Effect of AC-134 in Chronic Kidney Diseases

Taichung Veterans General Hospital

Status: Not yet enrolling

Conditions: Nephrology

Treatments: Other: Standard treatment; Dietary Supplement: Low protein diet with AC-134

Study type: Interventional

Funder types: Other

Identifiers

NCT06441435

SF23520C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group

Experimental group

Description:

Low-protein diet strategies combined with AC-134 capsules

Treatment:

Dietary Supplement: Low protein diet with AC-134

Control group

Active Comparator group

Description:

Low-protein diet strategies

Treatment:

Other: Standard treatment