The Effect of AC-134 in Chronic Kidney Diseases

NCT06441435 | Not Yet Recruiting

• 1 other identifier: SF23520C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrology

Keywords

Chronic Kidney Diseases; Activated charcoal

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Liver function

  Baseline to 3 months

• Inflammation makers

  Baseline to 3 months

• Nutrition status

  Baseline to 3 months

• Lipid analysis

  Baseline to 3 months

• Sugar test

  Baseline to 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Low-protein diet strategies combined with AC-134 capsules

Dietary Supplement: Low protein diet with AC-134

Control group

ACTIVE COMPARATOR

Low-protein diet strategies

Other: Standard treatment

Interventions

Low protein diet with AC-134 DIETARY_SUPPLEMENT

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

Intervention group

Standard treatment OTHER

Low protein diet

Control group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20-90 years.
• Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.
• Signed informed consent is required before enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• All Clean Health Co., Ltd: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, ROC, 40705, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anthrax

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Cheng-Hsu Chen, MDPHD

  Division of Nephrology in Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Ching Yang

CONTACT

(04)23592525; nutri1234@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 4, 2024
• Study Start: May 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

TW (1)