NCT00295191

Brief Summary

This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
704

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

November 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

4.3 years

First QC Date

February 22, 2006

Last Update Submit

October 3, 2011

Conditions

End-stage Renal DiseaseHemodialysis

Keywords

end-stage renal diseasehemodialysiscardiovascular morbidity and mortalityhigh flux dialyserultrapure dialysatecoronary vascular calcificationscarotid intima-media thicknessatherosclerosis

Outcome Measures

Primary Outcomes (1)

  • cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization

    three years

Secondary Outcomes (7)

  • overall mortality

    three years

  • progression of coronary artery calcification

    three years

  • progression of carotid artery intima-media thickness

    three years

  • changes in post-dialysis body weight

    three years

  • changes in upper mid-arm circumference

    three years

  • +2 more secondary outcomes

Study Arms (4)

1

ACTIVE COMPARATOR

high-flux dialyser

Procedure: high-flux membrane

2

ACTIVE COMPARATOR

low-flux dialyser

Procedure: low-flux membrane

3

ACTIVE COMPARATOR

conventional dialysate

Procedure: conventional dialysate

4

ACTIVE COMPARATOR

ultrapure dialysate

Procedure: ultrapure dialysate

Interventions

high-flux membranePROCEDURE

high-flux dialyser

1
low-flux membranePROCEDURE

low-flux dialyser

2
conventional dialysatePROCEDURE

conventional dialysate

3
ultrapure dialysatePROCEDURE

ultrapure dialysate

4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 80 years
  • On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
  • Willingness to participate in the study with a written informed consent.

You may not qualify if:

  • To be scheduled for living donor renal transplantation
  • To have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FMC Clinics

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Ege University School of Medicine

Bornova-Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

  • Ok ES, Asci G, Toz H, Ritz E, Kircelli F, Sever MS, Ozkahya M, Sipahi S, Dheir H, Bozkurt D, Omer Z, Sahin OZ, Ertilav M, Ok E. Glycated hemoglobin predicts overall and cardiovascular mortality in non-diabetic hemodialysis patients. Clin Nephrol. 2014 Sep;82(3):173-80. doi: 10.5414/cn108251.

    PMID: 25079862DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicAtherosclerosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ercan Ok, M.D

    Ege University School of Medicine Nephrology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 23, 2006

Study Start

November 1, 2005

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

TU(2)