Effect of Sevelamer on P-cresol Levels in CKD

Federico II University

Status and phase: Unknown; Phase 3

Conditions: Chronic Kidney Disease Stage 3-5

Treatments: Drug: Placebo; Drug: Sevelamer

Study type: Interventional

Funder types: Other

Identifiers

NCT02199444

P-C Sev

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Sevelamer

Experimental group

Description:

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

Treatment:

Drug: Sevelamer

Placebo

Placebo Comparator group

Description:

The patients received placebo three times a day

Treatment:

Drug: Placebo