Actively Recruiting
Circulating Long Noncoding RNA as a Biomarker to Assess the Therapeutic Impact of Oral Uremic Toxin Absorbent b1 Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease
Led by National Taiwan University Hospital · Updated on 2025-07-17
180
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying chronic kidney disease (CKD) patients who have a higher risk of developing peripheral artery disease (PAD), a condition affecting blood flow in the limbs. The study aims to evaluate the effects of a carbon-based oral adsorbent made from activated bamboo charcoal (ABC), with or without added probiotics, on vascular and endothelial function, cardiovascular outcomes, and mortality in these patients. They also plan to explore how circulating long noncoding RNA (lncRNA) and metabolome profiles may predict adverse cardiovascular events and death, while investigating the link between these biomarkers and gut microbiota imbalance in CKD patients with PAD. This is a randomized, open-label trial lasting 6 months, where 120 CKD patients with PAD and 60 healthy controls without PAD will be assigned to receive either the ABC treatment or no treatment. Participants in the treatment groups will take CharXenPlus containing 2g of ABC three times daily for 6 months. Additionally, probiotics will be given once daily during the last 3 months to some subgroups. Samples of urine, stool, and plasma will be collected and stored for further analysis. The trial includes detailed monitoring of kidney function, vascular health, and microbiota changes. Participants will undergo assessments at the start, at 3 months, and at 6 months, including tests such as the six-minute walk test and ankle-brachial index (ABI). Researchers will also measure changes in lncRNA, microbiota composition, endothelial progenitor cells, kidney function (eGFR), and albuminuria. The study will track cardiovascular, kidney, and limb health outcomes for up to 3 years. Privacy is protected by coded samples and data storage, with the option for participants to allow long-term storage of their samples for future research.
CONDITIONS
Brief Title
lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 20 years old on the day of screening.
- For patients: Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2 in stable condition, with creatinine rising less than 0.3 mg/dL in the past 30 days.
- For patients: Symptomatic peripheral artery disease with Rutherford Stage 2 or higher and ankle-brachial index less than 0.9 or documented by imaging.
- For controls: Age over 20 years old on the day of screening.
- For controls: eGFR greater than 60 ml/min/1.73m2.
- For controls: No clinical peripheral artery disease.
You will not qualify if you...
- Estimated glomerular filtration rate less than 15 ml/min/1.73m2.
- Severe malnutrition with albumin less than 2.0 g/dL.
- Severe anemia or active gastrointestinal bleeding with hemoglobin less than 8 g/dL.
- Peptic ulcer, esophageal varices, ileus, or fasting status.
- Previous gastrointestinal surgery.
- Chronic constipation defined by less than 3 bowel movements per week with straining or incomplete evacuation, unless relieved by laxatives.
- Recent major hemorrhage requiring blood transfusion.
- Advanced liver cirrhosis, Child classification B or C.
- Solid organ or blood transplantation recipients.
- Oliguric kidney injury producing less than 500 cc urine per day.
- Obstructive kidney injury or polycystic kidney disease.
- Antibiotics or probiotics treatment within 2 weeks before enrollment or during follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive oral activated bamboo charcoal with or without probiotics for 6 months to assess therapeutic impact on kidney disease and peripheral arterial disease.
Visits at baseline, 3 months, and 6 months for assessments
Trial Site Locations
Total: 1 location
1
NTUH
Taipei, Taiwan, Taiwan
Actively Recruiting
Research Team
C
Chau chung Wu
M
Mei-Chang Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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