End Stage Renal Disease Clinical Trial
— ACTIVEOfficial 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.
NCT number | NCT00649298 |
Other study ID # | GI-R-A001- 09 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | October 2014 |
Verified date | December 2019 |
Source | The George Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Australia | Royal Brisbane Hospital | Brisbane | Queensland |
Australia | The Canberra Hospital | Canberra | Australian Capital Territory |
Australia | Gold Coast Hospital | Gold Coast | 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 | Nambour General Hospital | Nambour | Queensland |
Australia | Sir Charles Gairdner Hospital | Perth | Western Australia |
Australia | Liverpool Hospital | Sydney | New South Wales |
Australia | RPAH/Concord | Sydney | New South Wales |
Australia | Sydney Adventist Hospital | Sydney | New South Wales |
Australia | Sydney Dialysis Centre | Sydney | New South Wales |
Canada | St Michael's Hospital | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Canada | UBC | Vancouver | British Columbia |
China | First Affiliated Hospital of Inner Mongolia, Baotou Medical College | Baotou | Inner Mongolia |
China | Beijing Hospital of Traditional Chinese Medicine | Beijing | Beijing |
China | Beijing Tongren Hospital | Beijing | Beijing |
China | Fourth Hospital Affiliated to Jilin University (FAW General Hospital) | Changchun | Jilin |
China | China-Japan Friendship Hospital | Chaoyang District | Beijing |
China | Civil Aviation General Hospital | Chaoyang District, | Beijing |
China | Huaxi Hospital of Sichuan University | Chengdu | Sichuan |
China | Dalian Medical affiliated first hospital | Dalian | Liaoning |
China | First Affiliated Hospital of Chinese PLA General Hospital | Haidian District | Beijing |
China | Zhongda Hospital, Southeast University | Nanjing | Jiangsu |
China | Shanghai Ruijin Hospital | Shanghai | Shanghai |
China | The Chinese PLA Shanghai 85th Hospital | Shanghai | Shanghai |
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 | The second affiliated hospital of Shanxi Medical University | Taiyuan City | Shanxi |
China | Beijing Hospital | Xicheng District | Beijing |
China | Peking University First Hospital | Xicheng District | Beijing |
China | Peking University People's Hospital | Xicheng District | Beijing |
China | Zhengzhou University affiliated first hospital | Zhengzhou | Henan |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | North Shore Hospital | Auckland |
Lead Sponsor | Collaborator |
---|---|
The George Institute | Baxter Healthcare Corporation, National Health and Medical Research Council, Australia |
Australia, Canada, China, New Zealand,
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 (Carl — View Citation
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 Qual — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Survival and cardiovascular analyses | 12 months | ||
Secondary | Quality of life and patient acceptability | 12 months | ||
Secondary | Safety outcomes | 12 months | ||
Secondary | Costs associated with each intervention | 12 months | ||
Secondary | Changes in biochemical and haematological parameters | 12 months |
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