A Clinical Trial of IntensiVE Dialysis (ACTIVE)

December 1, 2019 updated by: The George Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • The Canberra Hospital
    • New South Wales
      • Sydney, New South Wales, Australia, 2076
        • Sydney Adventist Hospital
      • Sydney, New South Wales, Australia
        • Liverpool Hospital
      • Sydney, New South Wales, Australia, 2050
        • RPAH/Concord
      • Sydney, New South Wales, Australia
        • Sydney Dialysis Centre
    • Queensland
      • Brisbane, Queensland, Australia
        • Princess Alexandra Hospital
      • Brisbane, Queensland, Australia
        • Royal Brisbane Hospital
      • Gold Coast, Queensland, Australia
        • Gold Coast Hospital
      • Nambour, Queensland, Australia
        • Nambour General Hospital
    • Tasmania
      • Hobart, Tasmania, Australia
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia
        • Austin Hospital
      • Melbourne, Victoria, Australia
        • Monash Medical Centre
    • Western Australia
      • Perth, Western Australia, Australia
        • Sir Charles Gairdner Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • UBC
    • Ontario
      • Toronto, Ontario, Canada
        • University Health Network
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital
  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tongren Hospital
      • Beijing, Beijing, China
        • Beijing Hospital of Traditional Chinese Medicine
      • Chaoyang District, Beijing, China
        • China-Japan Friendship Hospital
      • Chaoyang District,, Beijing, China
        • Civil Aviation General Hospital
      • Haidian District, Beijing, China
        • First Affiliated Hospital of Chinese PLA General Hospital
      • Xicheng District, Beijing, China
        • Beijing Hospital
      • Xicheng District, Beijing, China
        • Peking University First Hospital
      • Xicheng District, Beijing, China
        • Peking University People's Hospital
    • Guangdong
      • Shenzhen, Guangdong, China
        • Shenzhen Hospital of Peking University
    • Hebei
      • Shijiazhuang, Hebei, China
        • Fourth Hospital Affiliated to Hebei Medical University
      • Shijiazhuang, Hebei, China
        • Shijiazhuang First People's Hospital
      • Shijiazhuang, Hebei, China
        • Third Hospital Affiliated to Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China
        • Zhengzhou University affiliated first hospital
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • First Affiliated Hospital of Inner Mongolia, Baotou Medical College
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Zhongda Hospital, Southeast University
    • Jilin
      • Changchun, Jilin, China
        • Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
    • Liaoning
      • Dalian, Liaoning, China
        • Dalian Medical affiliated first hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Ruijin Hospital
      • Shanghai, Shanghai, China
        • The Chinese PLA Shanghai 85th Hospital
    • Shanxi
      • Taiyuan City, Shanxi, China
        • The Second Affiliated Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • Huaxi Hospital of Sichuan University
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
      • Auckland, New Zealand
        • North Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months from randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival and cardiovascular analyses
Time Frame: 12 months
12 months
Quality of life and patient acceptability
Time Frame: 12 months
12 months
Safety outcomes
Time Frame: 12 months
12 months
Costs associated with each intervention
Time Frame: 12 months
12 months
Changes in biochemical and haematological parameters
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute

Collaborators

National Health and Medical Research Council, Australia
Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Vlado Perkovic, MBBS PhD, The George Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-R-A001- 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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