Effect of Sevelamer on P-cresol Levels in CKD

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Sevelamer

Criteria

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.