NCT01397773

Brief Summary

The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

July 18, 2011

Last Update Submit

July 19, 2011

Conditions

InflammationChronic Kidney Disease

Keywords

Hemodialysisperitoneal dialysischronic kidney diseaseinflammationcarotis intima media thickness

Outcome Measures

Primary Outcomes (1)

  • Pentraxin-3 level

    Pentraxin-3 level will be compared with other inflammatory markers.

    Five months

Secondary Outcomes (1)

  • Carotis intima media thickness

    Five months

Study Arms (4)

Hemodialysis group

Patients on chronic hemodialysis program

Peritoneal dialysis group

Patients on chronic peritoneal dialysis program

Pre-dialysis group

Patients with chronic kidney disease stage-4

Control group

Healthy subjects

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected among those who are followed up in our clinic.

You may qualify if:

  • To give informed consent
  • Hemodialysis or peritoneal dialysis for more than 3 months
  • Creatinin clearance less than 30 ml/min for the pre-dialysis group

You may not qualify if:

  • Not to give informed concent
  • Active infection within the last 3 months
  • Known chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34390, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

InflammationRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

April 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

TU(1)