NCT00532597

Brief Summary

The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease patients on maintenance hemodialysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

September 19, 2007

Last Update Submit

September 19, 2007

Conditions

End Stage Renal DiseaseHemodialysis

Keywords

Vascular Endothelium-Dependent RelaxationHemodialysisHemodiafiltration

Outcome Measures

Primary Outcomes (1)

  • endothelial dysfunction measured by flow-mediated vasodilation

    4 months

Study Arms (2)

O

EXPERIMENTAL
Procedure: On-line hemodiafiltration

L

ACTIVE COMPARATOR
Procedure: Low flux hemodialysis

Interventions

On-line hemodiafiltrationPROCEDURE
O
Low flux hemodialysisPROCEDURE
L

Eligibility Criteria

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

You may qualify if:

  • end stage renal disease on maintenance hemodialysis for more than 3 months

You may not qualify if:

  • diagnosis of active cardiovascular diseases in 6 months
  • elevation of liver enzymes over two fold of upper normal limit in 3 months
  • admission for acute infection in 3 months
  • untreatable stenosis of vascular access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulji General Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

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 Symptoms

Study Officials

  • SuAh Sung, M.D.,PhD.

    Department of Internal Medicine, College of Medicine, Eulji University

    STUDY CHAIR

Central Study Contacts

Young-Hwan Hwang, M.D.

CONTACT

82-2-970-8457ondahl@eulji.ac.kr

Su-Ah Sung, M.D., PhD.

CONTACT

82-2-970-8205soi@eulji.ac.kr

Study Design

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

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 20, 2007

Study Start

April 1, 2007

Study Completion

March 1, 2008

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

KR(1)