Chronic Kidney Disease Stage 3-5 Clinical Trial
| NCT number | NCT02199444 |
| Other study ID # | P-C Sev |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | July 22, 2014 |
| Last updated | February 17, 2015 |
| Start date | June 2014 |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | federico II university, department of nephrology | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| Federico II University |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect on p-creol levels | The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy. | 3 months | No |