Effect of Sevelamer on P-cresol Levels in CKD

• Sponsor: Federico II University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02199444
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Stage 3-5	Drug: Sevelamer; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevelamer The dose of Sev was 2400 mg (800 mg three times a day) in all patients.	Drug: Sevelamer; The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
Placebo Comparator: Placebo The patients received placebo three times a day	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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   The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	federico II university, department of nephrology	Naples		Italy	80131

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eleonora Riccio, MD, Federico II University
• ClinicalTrials.gov Identifier: NCT02199444
• Other Study ID Numbers: P-C Sev
• First Posted: Jul 24, 2014
• Last Update Posted: Feb 18, 2015
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Sevelamer

Study Results

No Results Posted as of Feb 18, 2015