Clinical Study on Optimised Removal of Protein-Bound Uremic Toxins With Convective Dialysis Treatment.

This study is currently recruiting participants.

Verified by University Hospital, Ghent, December 2007

Sponsors and Collaborators:	University Hospital, Ghent Gambro Corporate Research, Sweden
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00337831

Purpose

Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).

Condition	Intervention
Chronic Renal Failure	Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Clinical Study on Optimised Removal of Protein-Bound Uremic Toxins With Convective Dialysis Treatment.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins?

Estimated Enrollment:	15
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

stable on hemodialysis >= 6 months
of which presently on high-flux HD >= 1 month
18 years < age < 85 years
blood flow rate >= 300ml/min

Exclusion Criteria:

expected survival < 1 year
expected transplant within < 1 year
infectious diseases
pregnancy
chronic inflammation condition
treated with single needle dialysis
presently treated with hemodiafiltration or low-flux hemodiafiltration
expected intradialytic body weight gain >= 4kg

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337831

Contacts

Contact: Natalie Meert, MD

0032(0)9/240.45.20

natalie.meert@UGent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Natalie Meert, MD 0032(0)9/240.45.20 natalie.meert@UGent.be
Principal Investigator: Natalie Meert, MD

Sponsors and Collaborators

University Hospital, Ghent

Gambro Corporate Research, Sweden

Investigators

Principal Investigator:

Raymond Vanholder, MD, PhD

University Hospital, Ghent

More Information

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

Study ID Numbers:	2006/127
Study First Received:	June 15, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00337831
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