NCT02199444

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

July 22, 2014

Last Update Submit

February 17, 2015

Conditions

Chronic Kidney Disease Stage 3-5

Outcome Measures

Primary Outcomes (1)

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    The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.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

Study Arms (2)

Sevelamer

EXPERIMENTAL

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

Drug: Sevelamer

Placebo

PLACEBO COMPARATOR

The patients received placebo three times a day

Drug: Placebo

Interventions

SevelamerDRUG

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

Sevelamer
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 years,
  • CKD stage 3-5

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

federico II university, department of nephrology

Naples, Italy, 80131, Italy

RECRUITING

Related Publications (1)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

MeSH Terms

Interventions

Sevelamer

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Central Study Contacts

eleonora riccio, md

CONTACT

3396770124elyriccio@libero.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 24, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Last Updated

February 18, 2015

Record last verified: 2014-09

Locations

IT(1)