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
  Purpose

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.


Condition Intervention Phase
Renal Replacement Therapy
Renal Dialysis
End Stage Kidney Disease
End Stage Renal Disease
Uremia
Procedure: haemodialysis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: October 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: extended hours
24 or more hours per week of hemodialysis
Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
  • Dialysis
  • Renal replacement therapy
Active Comparator: standard hours
18 or less hours per week of hemodialysis
Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
  • Dialysis
  • Renal replacement therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649298

  Show 40 Study Locations
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Investigators
Principal Investigator: Vlado Perkovic, MBBS PhD The George Institute
  More Information

Additional Information:
No publications provided by The George Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT00649298     History of Changes
Other Study ID Numbers: GI-R-A001- 09
Study First Received: March 25, 2008
Last Updated: August 17, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The George Institute:
Randomized Controlled Trial
Clinical Trial
Controlled Clinical Trial
Clinical Trial, Phase IV
Multicenter Study
End Stage Kidney Disease
Hemodialysis
Renal Dialysis
Renal Replacement Therapy
Nocturnal Dialysis
Extended dialysis
Quality of Life
Quality Adjusted Life Year
Hypertrophy, Left Ventricular
Blood Pressure
Hypertension
Anemia
Hematinics
Erythropoiesis Stimulating Agents
Cost-utility Analysis
Economic Evaluation
Health Care Utilisation
Health Care Costs
Health Expenditures
Hospitalization
Cost Analysis
Cardiovascular Diseases
Acute Coronary Syndrome
Myocardial Infarction
Stroke

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Uremia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014