The Effect of AC-134 in Chronic Kidney Diseases

Not Applicable

Not yet recruiting

• Conditions: Nephrology
• Interventions: Dietary Supplement: Low protein diet with AC-134; Other: Standard treatment

• Registration Number: NCT06441435
• Lead Sponsor: Taichung Veterans General Hospital

Brief 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.

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study Start: 2024-05-24
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Low protein diet with AC-134	Low-protein diet strategies combined with AC-134 capsules
Control group	Standard treatment	Low-protein diet strategies

Primary Outcome Measures

Name	Time	Method
Uremic toxins assay	Baseline to 3 months	The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples
Estimated glomerular filtration rate (eGFR) measurement	Baseline to 3 months	The eGFR level is a maker for kidney function
Blood Urea Nitrogen (BUN) levels	Baseline to 3 months	Blood Urea Nitrogen

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, ROC, Taiwan