A Clinical Trial of IntensiVE Dialysis (ACTIVE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00649298 |
Recruitment Status
:
Completed
First Posted
: April 1, 2008
Last Update Posted
: June 24, 2015
|
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 |
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 |
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 |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
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 |
|
|||
Intervention ICMJE | Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
|
|||
Study Arms |
|
|||
Publications * |
|
|||
* 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 |
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
Investigators ICMJE |
|
|||
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 |