Clinical trial NCT06441435: The Effect of AC-134 in Chronic Kidney Diseases
Official title: To Investigate the Protective Effect of AC 134 in Chronic Kidney Diseases.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nephrology
Keywords: Chronic Kidney Diseases
Activated charcoal
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: All Clean Health Co., Ltd
First posted: 2024-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimated glomerular filtration rate (eGFR) measurement
timeFrame: Baseline to 3 months
measure: Blood Urea Nitrogen (BUN) levels
timeFrame: Baseline to 3 months
measure: Uremic toxins assay
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Liver function
timeFrame: Baseline to 3 months
measure: Inflammation makers
timeFrame: Baseline to 3 months
measure: Nutrition status
timeFrame: Baseline to 3 months
measure: Lipid analysis
timeFrame: Baseline to 3 months
measure: Sugar test
timeFrame: Baseline to 3 months
measure: The quality of life
timeFrame: Baseline to 3 months
measure: Anemia test
timeFrame: Baseline to 3 months
measure: Urine protein analysis
timeFrame: Baseline to 3 months
measure: 24-hour Dietary recall
timeFrame: Baseline to 3 months
measure: Gastrointestinal symptoms measures
timeFrame: Baseline to 3 months
measure: Grip strength levels
timeFrame: Baseline to 3 months
measure: Blood gas
timeFrame: Baseline to 3 months
measure: Electrolytes Analysis
timeFrame: Baseline to 3 months
measure: Mitochondrial oxidative stress
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
state: ROC
Study officials:
affiliation: Division of Nephrology in Taichung Veterans General Hospital
name: Cheng-Hsu Chen, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: