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Effect of Sevelamer on P-cresol Levels in CKD

Primary Purpose

Chronic Kidney Disease Stage 3-5

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Sevelamer
Placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 3-5

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • federico II university, department of nephrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sevelamer

Placebo

Arm Description

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

The patients received placebo three times a day

Outcomes

Primary Outcome Measures

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The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.

Secondary Outcome Measures

Full Information

First Posted
July 22, 2014
Last Updated
February 17, 2015
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02199444
Brief Title
Effect of Sevelamer on P-cresol Levels in CKD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3-5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sevelamer
Arm Type
Experimental
Arm Description
The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients received placebo three times a day
Intervention Type
Drug
Intervention Name(s)
Sevelamer
Intervention Description
The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect on p-creol levels
Description
The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eleonora riccio, md
Phone
3396770124
Email
elyriccio@libero.it
Facility Information:
Facility Name
federico II university, department of nephrology
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eleonora riccio, md
Phone
3396770124
Email
elyriccio@libero.it
First Name & Middle Initial & Last Name & Degree
eleonora riccio, md

12. IPD Sharing Statement

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Effect of Sevelamer on P-cresol Levels in CKD

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