A Clinical Trial of IntensiVE Dialysis (ACTIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT00649298
First received: March 25, 2008
Last updated: August 17, 2014
Last verified: June 2013

March 25, 2008
August 17, 2014
May 2008
July 2014   (final data collection date for primary outcome measure)
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. [ Time Frame: 12 months from randomisation ] [ Designated as safety issue: No ]
The primary outcome assessed by the clinical trial will be the difference in the change in quality of life (QOL) between the two groups from randomisation to the 12 month follow up. The EuroQol EQ-5D instrument will be used to assess utility based QOL. [ Time Frame: 12 months from randomisation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00649298 on ClinicalTrials.gov Archive Site
  • Survival and cardiovascular analyses [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of life and patient acceptability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety outcomes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Costs associated with each intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in biochemical and haematological parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Safety of extended hours haemodialysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Durability of extended hours haemodialysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in systolic blood pressure taken as the average of 3 recumbent measurements taken after 5 minutes rest and measured on the day after a dialysis session [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pre-dialysis serum phosphate levels, calcium phosphate product levels, and dose of phosphate binders at 4 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Predialysis haemoglobin concentration and dose of erythropoietic agents at 4 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to the occurrence of a combined end-point consisting of new onset of acute myocardial infarction, stroke or death due to cardiovascular causes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to access failure, defined as thrombosis or stenosis of the fistula requiring revision [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • time to first access related infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Persistence of therapy at 24 months, 36 and 60 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Vital status at 24, 36 and 60 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • proportion of the individuals who are invited to participate in the study that then proceed to randomisation and receive at least one session of randomised therapy [ Time Frame: 2 months from randomisation ] [ Designated as safety issue: No ]
  • hospital admissions (days per year) excluding any admissions solely for routine dialysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • hospital admissions (events per year) excluding any admissions solely for routine dialysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • A formal cost-utility analysis will be conducted from the perspective of the health care provider to estimate cost per quality adjusted life year gained. Evaluations will be conducted for the whole patient group and for home and centre-based therapies. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • non-hospital health service use such as GP consultations and non-hospital medications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • employment status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • household financial stress as measured by whether individuals' report an inability, or the need for assistance, in making household payments in the previous 3 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • requirement for blood pressure lowering drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in left ventricular mass from baseline to 12 months measured by magnetic resonance imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Clinical Trial of IntensiVE Dialysis
ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Renal Replacement Therapy
  • Renal Dialysis
  • End Stage Kidney Disease
  • End Stage Renal Disease
  • Uremia
Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
  • Dialysis
  • Renal replacement therapy
  • Experimental: extended hours
    24 or more hours per week of hemodialysis
    Intervention: Procedure: haemodialysis
  • Active Comparator: standard hours
    18 or less hours per week of hemodialysis
    Intervention: Procedure: haemodialysis
Badve SV, Hawley CM, Johnson DW. Frequent versus standard hemodialysis. N Engl J Med. 2011 Mar 10;364(10):975; author reply 976. doi: 10.1056/NEJMc1100105#SA3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
October 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   China,   New Zealand
 
NCT00649298
GI-R-A001- 09
Yes
The George Institute
The George Institute
  • National Health and Medical Research Council, Australia
  • Baxter Healthcare Corporation
Principal Investigator: Vlado Perkovic, MBBS PhD The George Institute
The George Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP