Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2008-05-31
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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extended hours
24 or more hours per week of hemodialysis
haemodialysis
Comparison of different weekly duration of haemodialysis treatment
standard hours
18 or less hours per week of hemodialysis
haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Interventions
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haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Baxter Healthcare Corporation
INDUSTRY
The George Institute
OTHER
Responsible Party
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Principal Investigators
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Vlado Perkovic, MBBS PhD
Role: PRINCIPAL_INVESTIGATOR
The George Institute
Locations
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The Canberra Hospital
Canberra, Australian Capital Territory, Australia
RPAH/Concord
Sydney, New South Wales, Australia
Sydney Adventist Hospital
Sydney, New South Wales, 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, 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
Countries
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References
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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.
Smyth 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.
Jardine 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.
Zhan 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.
Liao 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.
Gray 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.
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. No abstract available.
Other Identifiers
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GI-R-A001- 09
Identifier Type: -
Identifier Source: org_study_id
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