A Clinical Trial of IntensiVE Dialysis (ACTIVE)

The George Institute

Status and phase: Completed; Phase 4

Conditions: Renal Replacement Therapy; End Stage Renal Disease; Uremia; End Stage Kidney Disease; Renal Dialysis

Treatments: Procedure: haemodialysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00649298

GI-R-A001- 09

Details and patient eligibility

About

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.

Full description

A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.

In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.

The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

extended hours

Experimental group

Description:

24 or more hours per week of hemodialysis

Treatment:

Procedure: haemodialysis

standard hours

Active Comparator group

Description:

18 or less hours per week of hemodialysis

Treatment:

Procedure: haemodialysis