The Effect of AC-134 in Chronic Kidney Diseases

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: Not yet recruiting
• Conditions: Nephrology
• Intervention / Treatment: Dietary supplement: Low protein diet with AC-134; Other: Standard treatment

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen-Ching Yang; Phone Number: 2626 (04)23592525; Email: nutri1234@vghtc.gov.tw

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Estimated glomerular filtration rate (eGFR) measurement	The eGFR level is a maker for kidney function	Baseline to 3 months
Blood Urea Nitrogen (BUN) levels	Blood Urea Nitrogen	Baseline to 3 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver function	The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples	Baseline to 3 months
Inflammation makers	The concentration of inflammation makers in the subjects' blood samples	Baseline to 3 months
Nutrition status	The concentration of albumin, wbc and uric acid in the subjects' blood samples	Baseline to 3 months
Lipid analysis	The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples	Baseline to 3 months
Sugar test	The concentration of fasting sugar and HbA1C in the subjects' blood samples	Baseline to 3 months
The quality of life	It will measure by the Kidney Disease Quality of Life ([KDQOL]-SF™) questionnaire	Baseline to 3 months
Anemia test	The concentration of hemoglobin (Hb) in the subject's blood samples	Baseline to 3 months
Urine protein analysis	Urine specimen collection will be evaluated on the spot and 24-hour urine protein	Baseline to 3 months
24-hour Dietary recall	There will be collected by food models or a photography atlas to estimate portion size	Baseline to 3 months
Gastrointestinal symptoms measures	There will be collected by questionnaires symptoms or chief complaints	Baseline to 3 months
Grip strength levels	Hand grip strength was measured by grip strength device	Baseline to 3 months
Blood gas	The concentration of blood gas test in the subject's blood samples	Baseline to 3 months
Electrolytes Analysis	The concentration of electrolytes analysis in the subject's blood samples	Baseline to 3 months
Mitochondrial oxidative stress	The concentration analysis in the subject's blood or urine samples, such as MDA	Baseline to 3 months

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Collaborators: All Clean Health Co., Ltd
• Investigators: Principal Investigator: Cheng-Hsu Chen, MDPHD, Division of Nephrology in Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 24, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Kidney Diseases; Activated charcoal
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID 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