The Effect of AC-134 in Chronic Kidney Diseases

NCT ID: NCT06441435

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Nephrology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention group

Low-protein diet strategies combined with AC-134 capsules

Group Type EXPERIMENTAL

Low protein diet with AC-134

Intervention Type DIETARY_SUPPLEMENT

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

Control group

Low-protein diet strategies

Group Type ACTIVE_COMPARATOR

Standard treatment

Intervention Type OTHER

Low protein diet

Interventions

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Low protein diet with AC-134

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

Intervention Type DIETARY_SUPPLEMENT

Standard treatment

Low protein diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All Clean Health Co., Ltd

UNKNOWN

Sponsor Role collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng-Hsu Chen, MDPHD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology in Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, ROC, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Wen-Ching Yang

Role: CONTACT

(04)23592525 ext. 2626

Other Identifiers

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SF23520C

Identifier Type: -

Identifier Source: org_study_id

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