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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 15, 2006

Last Updated Date

April 9, 2009

Start Date ^†

May 2006

Current 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?

Original 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?

Change History

Complete list of historical versions of study NCT00337831 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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).

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Chronic Renal Failure

Intervention ^†

Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Natalie Meert, MD

+ 32 9 332.45.20

natalie.meert@UGent.be

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00337831

Responsible Party

Natalie Meert, University Hospital Ghent

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Ghent

Collaborators ^††

Gambro Corporate Research, Sweden

Investigators ^†

Principal Investigator:

Raymond Vanholder, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.