Clinical trial NCT00649298: A Clinical Trial of IntensiVE Dialysis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Replacement Therapy
Renal Dialysis
End Stage Kidney Disease
End Stage Renal Disease
Uremia
Keywords: Randomized Controlled Trial
Clinical Trial
Controlled Clinical Trial
Clinical Trial, Phase IV
Multicenter Study
End Stage Kidney Disease
Hemodialysis
Renal Dialysis
Renal Replacement Therapy
Nocturnal Dialysis
Extended dialysis
Quality of Life
Quality Adjusted Life Year
Hypertrophy, Left Ventricular
Blood Pressure
Hypertension
Anemia
Hematinics
Erythropoiesis Stimulating Agents
Cost-utility Analysis
Economic Evaluation
Health Care Utilisation
Health Care Costs
Health Expenditures
Hospitalization
Cost Analysis
Cardiovascular Diseases
Acute Coronary Syndrome
Myocardial Infarction
Stroke
Cerebrovascular Disorders
Mortality
Arteriovenous Fistula
Arteriovenous Shunt, Surgical
Thrombosis
Infection
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Baxter Healthcare Corporation
First posted: 2008-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months from randomisation
Secondary outcomes:
measure: Survival and cardiovascular analyses
timeFrame: 12 months
measure: Quality of life and patient acceptability
timeFrame: 12 months
measure: Safety outcomes
timeFrame: 12 months
measure: Costs associated with each intervention
timeFrame: 12 months
measure: Changes in biochemical and haematological parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Sydney
country: Australia
facility: RPAH/Concord
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Dialysis Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Gold Coast
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Nambour
country: Australia
facility: Nambour General Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Vancouver
country: Canada
facility: UBC
state: British Columbia
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Chaoyang District,
country: China
facility: Civil Aviation General Hospital
state: Beijing
city: Chaoyang District
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Haidian District
country: China
facility: First Affiliated Hospital of Chinese PLA General Hospital
state: Beijing
city: Xicheng District
country: China
facility: Beijing Hospital
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital
state: Beijing
city: Xicheng District
country: China
facility: Peking University People's Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen Hospital of Peking University
state: Guangdong
city: Shijiazhuang
country: China
facility: Fourth Hospital Affiliated to Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang First People's Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Third Hospital Affiliated to Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Zhengzhou University affiliated first hospital
state: Henan
city: Baotou
country: China
facility: First Affiliated Hospital of Inner Mongolia, Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
city: Changchun
country: China
facility: Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
state: Jilin
city: Dalian
country: China
facility: Dalian Medical affiliated first hospital
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: The Chinese PLA Shanghai 85th Hospital
state: Shanghai
city: Taiyuan City
country: China
facility: The second affiliated hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Huaxi Hospital of Sichuan University
state: Sichuan
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
Study officials:
affiliation: The George Institute
name: Vlado Perkovic, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2019 Dec 6;14(12):1751-1762. doi: 10.2215/CJN.06800619. Epub 2019 Oct 31.
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 Quality of Life. J Am Soc Nephrol. 2017 Jun;28(6):1898-1911. doi: 10.1681/ASN.2015111225. Epub 2017 Feb 1.
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. BMC Nephrol. 2019 Jul 12;20(1):258. doi: 10.1186/s12882-019-1438-3.
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/nep.13236.
citation: 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.
citation: 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.