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CompletedNCT00337831Updated Jun 30, 2011

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

An interventional study of Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration in Chronic Renal Failure, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-06-30.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Chronic Renal Failure
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 17 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Interventions

  • ProcedurePerformance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

    Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00337831
Lead sponsor
University Hospital, Ghent
Collaborators
Gambro Corporate Research, Sweden
First posted
Jun 16, 2006
Start date
May 2006
Primary completion
Feb 2007
Completion
May 2007
Last update
Jun 30, 2011

Study contacts

Raymond Vanholder, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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