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

This study has been completed.
Sponsor:
Collaborator:
Gambro Corporate Research, Sweden
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00337831
First received: June 15, 2006
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.

Resource links provided by NLM:

U.S. FDA Resources

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? [ Time Frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min. ] [ Designated as safety issue: No ]
  • To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins? [ Time Frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min. ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
    Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
  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

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Gambro Corporate Research, Sweden
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

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

No publications provided

Responsible Party: Natalie Meert, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00337831     History of Changes
Other Study ID Numbers: 2006/127
Study First Received: June 15, 2006
Last Updated: June 29, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013