A Clinical Trial of IntensiVE Dialysis (ACTIVE)

Tracking Information
First Submitted Date ICMJE	March 25, 2008
First Posted Date ICMJE	April 1, 2008
Last Update Posted Date	June 24, 2015
Study Start Date ICMJE	May 2008
Actual Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 17, 2009)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: March 31, 2008)	The primary outcome assessed by the clinical trial will be the difference in the change in quality of life (QOL) between the two groups from randomisation to the 12 month follow up. The EuroQol EQ-5D instrument will be used to assess utility based QOL. [ Time Frame: 12 months from randomisation ]
Change History	Complete list of historical versions of study NCT00649298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 17, 2009)	Survival and cardiovascular analyses [ Time Frame: 12 months ]; Quality of life and patient acceptability [ Time Frame: 12 months ]; Safety outcomes [ Time Frame: 12 months ]; Costs associated with each intervention [ Time Frame: 12 months ]; Changes in biochemical and haematological parameters [ Time Frame: 12 months ]
Original Secondary Outcome Measures ICMJE; (submitted: March 31, 2008)	Safety of extended hours haemodialysis [ Time Frame: 12 months ]; Durability of extended hours haemodialysis [ Time Frame: 12 months ]; Change in systolic blood pressure taken as the average of 3 recumbent measurements taken after 5 minutes rest and measured on the day after a dialysis session [ Time Frame: 12 months ]; Pre-dialysis serum phosphate levels, calcium phosphate product levels, and dose of phosphate binders at 4 and 12 months [ Time Frame: 12 months ]; Predialysis haemoglobin concentration and dose of erythropoietic agents at 4 and 12 months [ Time Frame: 12 months ]; Time to the occurrence of a combined end-point consisting of new onset of acute myocardial infarction, stroke or death due to cardiovascular causes [ Time Frame: 12 months ]; Time to access failure, defined as thrombosis or stenosis of the fistula requiring revision [ Time Frame: 12 months ]; time to first access related infection [ Time Frame: 12 months ]; Persistence of therapy at 24 months, 36 and 60 months [ Time Frame: 12 months ]; Vital status at 24, 36 and 60 months [ Time Frame: 12 months ]; proportion of the individuals who are invited to participate in the study that then proceed to randomisation and receive at least one session of randomised therapy [ Time Frame: 2 months from randomisation ]; hospital admissions (days per year) excluding any admissions solely for routine dialysis [ Time Frame: 12 months ]; hospital admissions (events per year) excluding any admissions solely for routine dialysis [ Time Frame: 12 months ]; A formal cost-utility analysis will be conducted from the perspective of the health care provider to estimate cost per quality adjusted life year gained. Evaluations will be conducted for the whole patient group and for home and centre-based therapies. [ Time Frame: 12 months ]; non-hospital health service use such as GP consultations and non-hospital medications [ Time Frame: 12 months ]; employment status [ Time Frame: 12 months ]; household financial stress as measured by whether individuals' report an inability, or the need for assistance, in making household payments in the previous 3 months [ Time Frame: 12 months ]; requirement for blood pressure lowering drugs [ Time Frame: 12 months ]; change in left ventricular mass from baseline to 12 months measured by magnetic resonance imaging [ Time Frame: 12 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Clinical Trial of IntensiVE Dialysis
Official Title ICMJE	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Renal Replacement Therapy; Renal Dialysis; End Stage Kidney Disease; End Stage Renal Disease; Uremia
Intervention ICMJE	Procedure: haemodialysis; Comparison of different weekly duration of haemodialysis treatment; Other Names: Dialysis; Renal replacement therapy
Study Arms	Experimental: extended hours 24 or more hours per week of hemodialysis Intervention: Procedure: haemodialysis; Active Comparator: standard hours 18 or less hours per week of hemodialysis Intervention: Procedure: haemodialysis
Publications *	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.; 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.; Eriguchi R, Taniguchi M, Ninomiya T, Hirakata H, Fujimi S, Tsuruya K, Kitazono T. Hyporesponsiveness to erythropoiesis-stimulating agent as a prognostic factor in Japanese hemodialysis patients: the Q-Cohort study. J Nephrol. 2015 Apr;28(2):217-25. doi: 10.1007/s40620-014-0121-9. Epub 2014 Jul 31.; 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#SA3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 31, 2008)	200
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2014
Actual Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Canada, China, New Zealand
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00649298
Other Study ID Numbers ICMJE	GI-R-A001- 09
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	The George Institute
Study Sponsor ICMJE	The George Institute
Collaborators ICMJE	National Health and Medical Research Council, Australia; Baxter Healthcare Corporation
Investigators ICMJE	Principal Investigator: Vlado Perkovic, MBBS PhD The George Institute
PRS Account	The George Institute
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP