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New treatment option for CKD
Official title lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD
ClinicalTrials.gov ID: NCT04788914
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.