NCT04788914Recruiting
lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD
Circulating Long Noncoding RNA as a Biomarker to Assess the Therapeutic Impact of Oral Uremic Toxin Absorbent ± Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 19 May 2020
- Start date
- 21 Apr 2020
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT04788914
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 21 Apr 2020 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal operation.
- Solid organ or hematological transplantation recipients.
- Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.
Other illness
- Peptic ulcer, esophageal varices, ileus or under fasting status
- Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Evidence of obstructive kidney injury or polycystic kidney disease.
Lab values
- Baseline estimated glomerular filtration rates (eGFR) \< 15 ml/min/1.73m2 according to MDRD equation.
- Patients in severe malnutrition status, albumin less than 2.0 g/dL
- Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL.
Other
- Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.
- Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
- Patients with oliguric kidney injury, as defined with less than 500 cc/day.
Who the study is looking for
- I: Patients
- Age \> 20 years old on the day of screening.
- CKD patients with eGFR 15 \< eGFR \< 60 ml/min/1.73m2 in a stable status, creatinine elevated less than 0.3 mg/dL in at least 30 days before enrollment.
- Symptomatic PAD with Rutherford Stage ≥ 2 and ABI \< 0.9 (or documented by CT-angio, vascular duplex, etc.).
- II: Controls
- Age \> 20 years old on the day of screening.
- With eGFR \> 60 ml/min/1.73m2
- No clinical PAD.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NTUH Coordinator of this site? Confirm its status | Taipei, Taiwan | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.