NCT04788914 lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD
| NCT ID | NCT04788914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | CKD |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-04-21 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2020-04-21 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: I: Patients 1. Age \> 20 years old on the day of screening. 2. 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. 3. Symptomatic PAD with Rutherford Stage ≥ 2 and ABI \< 0.9 (or documented by CT-angio, vascular duplex, etc.). II: Controls 1. Age \> 20 years old on the day of screening. 2. With eGFR \> 60 ml/min/1.73m2 3. No clinical PAD. Exclusion Criteria: 1. Baseline estimated glomerular filtration rates (eGFR) \< 15 ml/min/1.73m2 according to MDRD equation. 2. Patients in severe malnutrition status, albumin less than 2.0 g/dL 3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL. 4. Peptic ulcer, esophageal varices, ileus or under fasting status 5. Previous gastrointestinal operation. 6. 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. 7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission. 8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C. 9. Solid organ or hematological transplantation recipients. 10. Patients with oliguric kidney injury, as defined with less than 500 cc/day. 11. Evidence of obstructive kidney injury or polycystic kidney disease. 12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.
Contact & Investigator
Chau chung Wu
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT04788914 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying CKD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04788914 currently recruiting?
Yes, NCT04788914 is actively recruiting participants. Contact the research team at Chauchungwu@ntu.edu.tw for enrollment information.
Where is the NCT04788914 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taiwan.
Who is sponsoring the NCT04788914 clinical trial?
NCT04788914 is sponsored by National Taiwan University Hospital. The principal investigator is Chau chung Wu at National Taiwan University Hospital. The trial plans to enroll 180 participants.