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lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD

RecruitingNAAges 20 Years - anyAllNational Taiwan University Hospital
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In plain words

What the trial is, and whether it could suit you

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 bam

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📋 Eligibility rules (as published)
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.
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What it tests

  • Active bamboo charcoal± probiotics
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Where

1 site
NTUH
Taipei, Taiwan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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