NCT00411177

Brief Summary

This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
782

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Typical duration 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

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

3 years

First QC Date

December 12, 2006

Last Update Submit

September 6, 2013

Conditions

End-Stage Renal Disease

Keywords

end-stage renal diseasehemodialysiscardiovascular morbidity and mortalityhigh flux dialyseron-line hemodiafiltrationarterial stiffnessinflammationlife qualityleft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.

    two years

Secondary Outcomes (7)

  • cardiovascular mortality

    two years

  • hospitalization rate

    two years

  • intradialytic complications including hypotension and cramp

    two years

  • health-related quality of life, depression burden, cognitive function

    two years

  • required medications

    two years

  • +2 more secondary outcomes

Study Arms (2)

Post-dilution on-line hemodiafiltration

ACTIVE COMPARATOR

Post-dilution on-line hemodiafiltration

Procedure: post-dilution on-line hemodiafiltration

High-flux hemodialysis

OTHER

High-flux hemodialysis

Procedure: high flux hemodialysis

Interventions

post-dilution on-line hemodiafiltrationPROCEDURE

post-dilution on-line hemodiafiltration, 3 times a week 4 hours

Post-dilution on-line hemodiafiltration
high flux hemodialysisPROCEDURE

High-flux hemodialysis, 3 times a week 4 hours

Also known as: High-flux hemodialysis
High-flux hemodialysis

Eligibility Criteria

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

You may qualify if:

  • older than 18 years
  • on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
  • 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
  • Current requirement for HD more than three times per week due to medical comorbidity
  • GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
  • Use of temporary catheter
  • Insufficient vascular access (blood flow rate lower than 250 ml/min)
  • Mental incompetence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ege University School of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

FMC Clinics Turkey

Adana, 01000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, ChronicInflammationHypertrophy, Left Ventricular

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 SymptomsCardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, Anatomical

Study Officials

  • Ercan Ok, MD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations

TU(2)