Status:
RECRUITING
lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD
Lead Sponsor:
National Taiwan University Hospital
Conditions:
CKD
PAD
Eligibility:
All Genders
20+ years
Phase:
NA
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 sul...
Detailed Description
This is a prospective, randomized, open-labeled, blinded end-point (so called PROBE) trial for 6 months. All patients presented to the clinics of participating sites with advanced CKD with eGFR 15 \< ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Peptic ulcer, esophageal varices, ileus or under fasting status
- Previous gastrointestinal operation.
- 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 major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
- Solid organ or hematological transplantation recipients.
- Patients with oliguric kidney injury, as defined with less than 500 cc/day.
- Evidence of obstructive kidney injury or polycystic kidney disease.
- Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04788914
Start Date
April 21 2020
End Date
July 31 2025
Last Update
July 17 2025
Active Locations (1)
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1
NTUH
Taipei, Taiwan, Taiwan