Actively Recruiting
lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD
Led by National Taiwan University Hospital · Updated on 2025-07-17
180
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Participants with chronic kidney disease (CKD) are at a higher risk of developing atherosclerotic peripheral artery disease (PAD). Retention of uremic toxins such as indoxyl sulfate (IS), p-cresyl sulfate (PCS) and trimethylamine N-oxide (TMAO) during CKD is detrimental to endothelial and vascular function and can predispose to the development and progression of PAD. Many of the uremic toxins originate from gut microbial metabolism. Removal of these uremic toxins by carbonaceous oral adsorbent is beneficial, slowing down the deterioration of renal function and delaying the need for dialysis in CKD patients. However, if carbonaceous oral adsorbent could also improve vascular function and clinical outcomes in CKD patients with established PAD, remains unknown. In this proposal, the investigators aim to determine the therapeutic impact of a carbonaceous oral adsorbent made of activated bamboo charcoal (ABC) with/without probiotics on the endothelial/vascular function, CV outcome and mortality in CKD patients with PAD. In addition, the investigators hypothesize that circulating long noncoding RNA (lncRNA) expression profiles and metabolome may serve as a sensitive and reliable biomarker to predict the adverse CV outcomes and death in CKD patients with established PAD. In addition, it is hypothesized that circulating lncRNAs and linked to adverse CV outcomes in CKD patients with PAD are associated with dysbiosis of gut microbiota. The investigators also hypothesize that the administration of ABC could normalize the dysbiosis of gut microbiota, dysregulated circulating lncRNAs and metabolome that are linked to adverse CV/limb outcomes in CKD patients with PAD. This will be a prospective, randomized, open-labeled, blinded end-point trial for 6 months, followed by integrated assessment of endothelial/vascular function, changes in conventional athero- and inflammation-relevant biomarkers, circulating long noncoding RNAs, metabolome, and gut microbiota at baseline, ends of the 3rd and 6th month, as well as clinical CV, renal and limb outcomes up to 3 years.
CONDITIONS
Official 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 greater than 20 years old on the day of screening.
- For patients: CKD with eGFR between 15 and 60 ml/min/1.73m2 in stable condition, with creatinine elevation 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 PAD by imaging.
- For controls: Age greater than 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...
- Baseline 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 as fewer than 3 bowel movements per week with associated symptoms (patients using oral laxatives to achieve bowel movements are not excluded).
- Major hemorrhage requiring blood transfusion during index admission.
- Advanced liver cirrhosis classified as Child B or C.
- Solid organ or hematological transplant recipients.
- Oliguric kidney injury with urine output less than 500 cc/day.
- Obstructive kidney injury or polycystic kidney disease.
- Antibiotics or probiotics treatment within 2 weeks before enrollment or during follow-up.
AI-Screening
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Trial Site Locations
Total: 1 location
1
NTUH
Taipei, Taiwan, Taiwan
Actively Recruiting
Research Team
C
Chau chung Wu
CONTACT
M
Mei-Chang Huang
CONTACT
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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