CompletedPhase 4

A Clinical Trial of IntensiVE Dialysis

Australia200 participantsStarted 2008-05

Plain-language summary

This study will assess clinical outcomes of extended weekly hours of haemodialysis (\>= 24 hours per week) compared with standard hours of haemodialysis (\<=18 hours/week) in people with ESKD.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
✓. Aged 18 years or older
✓. Undergoing dialysis for 18 hours per week or less
✓. Suitable for either extended or standard dialysis in the view of the treating physician
✓. Agreeable to randomisation

Exclusion criteria

✕. Life expectancy of less than 6 months
✕. Definite plans to undergo renal transplantation within 12 months of entry to the study
✕. Inability to complete quality of life questionnaire
✕. Concomitant major illness that would limit assessments and followup
✕. High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.

What they're measuring

The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument.

Timeframe: 12 months from randomisation

Trial details

NCT IDNCT00649298

SponsorThe George Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Renal Replacement Therapy trials