Effect of Sevelamer on P-cresol Levels in CKD

Phase 3UnknownNCT02199444

Federico II University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Chronic Kidney Disease Stage 3-5

Interventions

SevelamerDRUG

The dose of Sev was 2400 mg (800 mg three times a day) in all patients.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

federico II university, department of nephrology

Naples, Italy, Italy

RECRUITING

Outcomes

Primary Outcomes

Effect on p-creol levels

The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.

Time frame: 3 months

Central Contacts

eleonora riccio, md

CONTACT

3396770124 elyriccio@libero.it

Data from ClinicalTrials.gov

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