Chronic Kidney Disease Stage 3-5
Conditions
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.
Interventions
DRUGSevelamer
The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
DRUGPlacebo
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on p-creol levels | 3 months | The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy. |
Countries
Italy
Contacts
Primary Contacteleonora riccio, md
Outcome results
None listed