Effect of Sevelamer on P-cresol Levels in CKD
- Registration Number
- NCT02199444
- Lead Sponsor
- Federico II University
- Brief Summary
The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- age >18 years,
- CKD stage 3-5
Exclusion Criteria
- Existing or previous treatment within the last 1 year with a phosphate binder;
- hyperphosphatemia (>5.6 mg/dL);
- hypophosphatemia (<2.5 mg/dL);
- malnutrition,
- malignant neoplasms,
- current history of gastrointestinal and/or endocrine diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sevelamer Sevelamer The dose of Sev was 2400 mg (800 mg three times a day) in all patients. Placebo Placebo The patients received placebo three times a day
- Primary Outcome Measures
Name Time Method Effect on p-creol levels 3 months The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
federico II university, department of nephrology
🇮🇹Naples, Italy