A Clinical Trial of IntensiVE Dialysis
ACTIVE
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.
1 other identifier
interventional
200
4 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2008
Longer than P75 for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 3, 2019
December 1, 2019
6.2 years
March 25, 2008
December 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 months from randomisation
Secondary Outcomes (5)
Survival and cardiovascular analyses
12 months
Quality of life and patient acceptability
12 months
Safety outcomes
12 months
Costs associated with each intervention
12 months
Changes in biochemical and haematological parameters
12 months
Study Arms (2)
extended hours
EXPERIMENTAL24 or more hours per week of hemodialysis
standard hours
ACTIVE COMPARATOR18 or less hours per week of hemodialysis
Interventions
Comparison of different weekly duration of haemodialysis treatment
Eligibility Criteria
You may qualify if:
- Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- Aged 18 years or older
- Undergoing dialysis for 18 hours per week or less
- Suitable for either extended or standard dialysis in the view of the treating physician
- Agreeable to randomisation
You may not qualify if:
- Life expectancy of less than 6 months
- Definite plans to undergo renal transplantation within 12 months of entry to the study
- Inability to complete quality of life questionnaire
- Concomitant major illness that would limit assessments and followup
- High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institutelead
- National Health and Medical Research Council, Australiacollaborator
- Baxter Healthcare Corporationcollaborator
Study Sites (40)
The Canberra Hospital
Canberra, Australian Capital Territory, Australia
RPAH/Concord
Sydney, New South Wales, 2050, Australia
Sydney Adventist Hospital
Sydney, New South Wales, 2076, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Sydney Dialysis Centre
Sydney, New South Wales, Australia
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
Royal Hobart Hospital
Hobart, Tasmania, Australia
Austin Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
UBC
Vancouver, British Columbia, Canada
St Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
University Health Network
Toronto, Ontario, Canada
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Civil Aviation General Hospital
Chaoyang District,, Beijing Municipality, China
China-Japan Friendship Hospital
Chaoyang District, Beijing Municipality, China
First Affiliated Hospital of Chinese PLA General Hospital
Haidian District, Beijing Municipality, China
Beijing Hospital
Xicheng District, Beijing Municipality, China
Peking University First Hospital
Xicheng District, Beijing Municipality, China
Peking University People's Hospital
Xicheng District, Beijing Municipality, China
Shenzhen Hospital of Peking University
Shenzhen, Guangdong, 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
Shijiazhuang, Hebei, China
Zhengzhou University affiliated first hospital
Zhengzhou, Henan, China
First Affiliated Hospital of Inner Mongolia, Baotou Medical College
Baotou, Inner Mongolia, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
Changchun, Jilin, China
Dalian Medical affiliated first hospital
Dalian, Liaoning, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
The Chinese PLA Shanghai 85th Hospital
Shanghai, Shanghai Municipality, China
The second affiliated hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Huaxi Hospital of Sichuan University
Chengdu, Sichuan, China
Auckland City Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Related Publications (7)
Jardine MJ, Zuo LI, Gray NA, de Zoysa J, Chan CT, Gallagher MP, Howard K, Hertier S, Cass A, Perkovic V; ACTIVE Dialysis Steering Committee. Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': the ACTIVE Dialysis Study. Nephrology (Carlton). 2015 Apr;20(4):257-65. doi: 10.1111/nep.12385.
PMID: 25529309BACKGROUNDSmyth B, van den Broek-Best O, Hong D, Howard K, Rogers K, Zuo L, Gray NA, de Zoysa JR, Chan CT, Lin H, Zhang L, Xu J, Cass A, Gallagher M, Perkovic V, Jardine M. Varying Association of Extended Hours Dialysis with Quality of Life. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1751-1762. doi: 10.2215/CJN.06800619. Epub 2019 Oct 31.
PMID: 31672793RESULTJardine MJ, Zuo L, Gray NA, de Zoysa JR, Chan CT, Gallagher MP, Monaghan H, Grieve SM, Puranik R, Lin H, Eris JM, Zhang L, Xu J, Howard K, Lo S, Cass A, Perkovic V; ACTIVE Dialysis Steering Committee; Paul. A Trial of Extending Hemodialysis Hours and Quality of Life. J Am Soc Nephrol. 2017 Jun;28(6):1898-1911. doi: 10.1681/ASN.2015111225. Epub 2017 Feb 1.
PMID: 28151412RESULTZhan Z, Smyth B, Toussaint ND, Gray NA, Zuo L, de Zoysa JR, Chan CT, Jin C, Scaria A, Hawley CM, Perkovic V, Jardine MJ, Zhang L. Effect of extended hours dialysis on markers of chronic kidney disease-mineral and bone disorder in the ACTIVE Dialysis study. BMC Nephrol. 2019 Jul 12;20(1):258. doi: 10.1186/s12882-019-1438-3.
PMID: 31299919RESULTLiao JL, van den Broek-Best O, Smyth B, Hong D, Vo K, Zuo L, Gray NA, Chan CT, de Zoysa J, Perkovic V, Jiang L, Jardine M. Effect of extended hours dialysis on sleep quality in a randomized trial. Nephrology (Carlton). 2019 Apr;24(4):430-437. doi: 10.1111/nep.13236.
PMID: 29424935RESULTGray NA, Zuo L, Hong D, Smyth B, Jun M, De Zoysa J, Vo K, Howard K, Wang J, Lu C, Liu Z, Cass A, Perkovic V, Jardine M. Quality of life in caregivers compared with dialysis recipients: The Co-ACTIVE sub-study of the ACTIVE dialysis trial. Nephrology (Carlton). 2019 Oct;24(10):1056-1063. doi: 10.1111/nep.13530. Epub 2019 Apr 29.
PMID: 30723975RESULTBadve 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. No abstract available.
PMID: 21388319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vlado Perkovic, MBBS PhD
The George Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2008
First Posted
April 1, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2014
Study Completion
October 1, 2014
Last Updated
December 3, 2019
Record last verified: 2019-12