Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis - Full Text View

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00766792

Purpose

Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.

Condition	Intervention
Chronic Renal Failure	Procedure: Nocturnal dialysis Procedure: Standard dialysis

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis? [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	December 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nocturnal dialysis	Procedure: Nocturnal dialysis Switch to nocturnal dialysis (3 times 480 min/week)
2: Active Comparator Standard dialysis	Procedure: Standard dialysis Standard dialysis (3 times 240-270 min/week)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age > 18 years

Exclusion Criteria:

pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766792

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Raymond Vanholder, MD, PhD

University Hospital, Ghent

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Responsible Party:	University Hospital Ghent ( Raymond Vanholder )
Study ID Numbers:	2005/288
Study First Received:	October 3, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00766792
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009