NCT00413803

Brief Summary

The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

1.2 years

First QC Date

December 19, 2006

Last Update Submit

August 3, 2009

Conditions

End-Stage Renal DiseaseHemodialysis

Keywords

HemodialysisNocturnal dialysisCardiovascular diseaseQuality of Lifeleft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • total mortality

    one year

Secondary Outcomes (9)

  • cardiovascular mortality

    one year

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

    one year

  • required medications

    one year

  • total cost

    one year

  • changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness,upper mid-arm circumference,hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin

    one year

  • +4 more secondary outcomes

Study Arms (2)

1

OTHER

Four-hour dialysis session, blood flow rate 300-400 ml/min

Procedure: 4-hour thrice weekly in center hemodialysis

2

ACTIVE COMPARATOR

Eight-hours dialysis session, blood flow rate 200-250 ml/min

Procedure: 8-hour thrice weekly in center hemodialysis

Interventions

4-hour thrice weekly in center hemodialysisPROCEDURE

conventional hemodialysis

1
8-hour thrice weekly in center hemodialysisPROCEDURE

long dialysis

2

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
  • Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
  • Mental incompetence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FMC Turkey Clinics

Adana, 01100, Turkey (Türkiye)

Location

Ege University School of Medicine Nephrology Department

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

  • Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.

    PMID: 22172590DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicCardiovascular DiseasesHypertrophy, 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 DiseasesHypertrophyPathological Conditions, Anatomical

Study Officials

  • Ercan Ok, MD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 20, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

TU(2)