A Clinical Trial of IntensiVE Dialysis (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00649298
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : June 24, 2015
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Information provided by (Responsible Party):
The George Institute

Brief 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.

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

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : May 2008
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Survival and cardiovascular analyses [ Time Frame: 12 months ]
  2. Quality of life and patient acceptability [ Time Frame: 12 months ]
  3. Safety outcomes [ Time Frame: 12 months ]
  4. Costs associated with each intervention [ Time Frame: 12 months ]
  5. Changes in biochemical and haematological parameters [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00649298

  Hide Study Locations
Australia, Australian Capital Territory
The Canberra Hospital
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Sydney, New South Wales, Australia, 2050
Sydney Adventist Hospital
Sydney, New South Wales, Australia, 2076
Liverpool Hospital
Sydney, New South Wales, Australia
Sydney Dialysis Centre
Sydney, New South Wales, Australia
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Brisbane, Queensland, Australia
Gold Coast Hospital
Gold Coast, Queensland, Australia
Nambour General Hospital
Nambour, Queensland, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada
China, Beijing
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing, China
Beijing Tongren Hospital
Beijing, Beijing, China
Civil Aviation General Hospital
Chaoyang District,, Beijing, China
China-Japan Friendship Hospital
Chaoyang District, Beijing, China
First Affiliated Hospital of Chinese PLA General Hospital
Haidian district, Beijing, China
Beijing Hospital
Xicheng District, Beijing, China
Peking University First Hospital
Xicheng District, Beijing, China
Peking University People's Hospital
Xicheng District, Beijing, China
China, Guangdong
Shenzhen Hospital of Peking University
Shenzhen, Guangdong, China
China, Hebei
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
Shijiazhuang, Hebei, China
China, Henan
Zhengzhou University affiliated first hospital
Zhengzhou, Henan, China
China, Inner Mongolia
First Affiliated Hospital of Inner Mongolia, Baotou Medical College
Baotou, Inner Mongolia, China
China, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
China, Jilin
Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
Changchun, Jilin, China
China, Liaoning
Dalian Medical affiliated first hospital
Dalian, Liaoning, China
China, Shanghai
Shanghai Ruijin Hospital
Shanghai, Shanghai, China
The Chinese PLA Shanghai 85th Hospital
Shanghai, Shanghai, China
China, Shanxi
The second affiliated hospital of Shanxi Medical University
Taiyuan City, Shanxi, China
China, Sichuan
Huaxi Hospital of Sichuan University
Chengdu, Sichuan, China
New Zealand
Auckland City Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Principal Investigator: Vlado Perkovic, MBBS PhD The George Institute

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: The George Institute Identifier: NCT00649298     History of Changes
Other Study ID Numbers: GI-R-A001- 09
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2013

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency