The Effect of AC-134 in Chronic Kidney Diseases

Nephrology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441435
• Other study ID #: SF23520C
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Taichung Veterans General Hospital
• Contact: Wen-Ching Yang
• Phone: (04)23592525
• Email: nutri1234[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Nephrology
• Renal Insufficiency, Chronic

Intervention

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

Other:
• Standard treatment
Low protein diet

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung	ROC

Sponsors (2)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital	All Clean Health Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated glomerular filtration rate (eGFR) measurement	The eGFR level is a maker for kidney function	Baseline to 3 months
Primary	Blood Urea Nitrogen (BUN) levels	Blood Urea Nitrogen	Baseline to 3 months
Primary	Uremic toxins assay	The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples	Baseline to 3 months
Secondary	Liver function	The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples	Baseline to 3 months
Secondary	Inflammation makers	The concentration of inflammation makers in the subjects' blood samples	Baseline to 3 months
Secondary	Nutrition status	The concentration of albumin, wbc and uric acid in the subjects' blood samples	Baseline to 3 months
Secondary	Lipid analysis	The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples	Baseline to 3 months
Secondary	Sugar test	The concentration of fasting sugar and HbA1C in the subjects' blood samples	Baseline to 3 months
Secondary	The quality of life	It will measure by the Kidney Disease Quality of Life ([KDQOL]-SF™) questionnaire	Baseline to 3 months
Secondary	Anemia test	The concentration of hemoglobin (Hb) in the subject's blood samples	Baseline to 3 months
Secondary	Urine protein analysis	Urine specimen collection will be evaluated on the spot and 24-hour urine protein	Baseline to 3 months
Secondary	24-hour Dietary recall	There will be collected by food models or a photography atlas to estimate portion size	Baseline to 3 months
Secondary	Gastrointestinal symptoms measures	There will be collected by questionnaires symptoms or chief complaints	Baseline to 3 months
Secondary	Grip strength levels	Hand grip strength was measured by grip strength device	Baseline to 3 months
Secondary	Blood gas	The concentration of blood gas test in the subject's blood samples	Baseline to 3 months
Secondary	Electrolytes Analysis	The concentration of electrolytes analysis in the subject's blood samples	Baseline to 3 months
Secondary	Mitochondrial oxidative stress	The concentration analysis in the subject's blood or urine samples, such as MDA	Baseline to 3 months