A Clinical Trial of IntensiVE Dialysis (ACTIVE)
This study is currently recruiting participants.
Verified March 2012 by The George Institute
Sponsor:
The George Institute
Collaborators:
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT00649298
First received: March 25, 2008
Last updated: March 19, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Replacement Therapy Renal Dialysis End Stage Kidney Disease End Stage Renal Disease Uremia |
Procedure: haemodialysis |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by The George Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival and cardiovascular analyses [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Quality of life and patient acceptability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Safety outcomes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Costs associated with each intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Changes in biochemical and haematological parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: extended hours
24 or more hours per week
|
Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
|
|
Active Comparator: standard hours
18 or less hours per week
|
Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649298
Contacts
| Contact: Helen Monaghan | +61 2 9993 4500 | hmonaghan@georgeinstitute.org.au |
| Contact: Ayana Ono | +61 2 9993 4500 | aono@georgeclinical.com |
Locations
| Australia, Australian Capital Territory | |
| The Canberra Hospital | Completed |
| Canberra, Australian Capital Territory, Australia | |
| Australia, New South Wales | |
| Sydney Dialysis Centre | Recruiting |
| Sydney, New South Wales, Australia | |
| Contact: Cheryl McAdam | |
| Contact: Bruce Cooper, MBBS PhD | |
| Principal Investigator: Bruce Cooper, MBBS PhD | |
| Sydney Adventist Hospital | Completed |
| Sydney, New South Wales, Australia, 2076 | |
| Statewide Renal Services | Recruiting |
| Sydney, New South Wales, Australia, 2050 | |
| Contact: Jenny Burman | |
| Principal Investigator: Martin Gallagher, MBBS MPH | |
| Sub-Investigator: Paul Snelling, MBChB BMedSc | |
| Sub-Investigator: Josette Eris, MBBS PhD | |
| Liverpool Hospital | Recruiting |
| Sydney, New South Wales, Australia | |
| Contact: Glenda Rayment | |
| Contact: Belinda Yip | |
| Principal Investigator: Michael Suranyi, MBBS PhD | |
| Australia, Queensland | |
| Princess Alexandra Hospital | Recruiting |
| Brisbane, Queensland, Australia | |
| Contact: Joanna Sudak | |
| Principal Investigator: Carolyn van Epps, MBBS | |
| Sub-Investigator: Carmel Hawley | |
| Sub-Investigator: Scott Campbell | |
| Sub-Investigator: David Johnson | |
| Sub-Investigator: Nicole Isbel | |
| Royal Brisbane Hospital | Completed |
| Brisbane, Queensland, Australia | |
| Gold Coast Hospital | Recruiting |
| Gold Coast, Queensland, Australia | |
| Contact: Jane Handsley | |
| Contact: Louise Macleod | |
| Principal Investigator: Murthy Divi | |
| Nambour General Hospital | Recruiting |
| Nambour, Queensland, Australia | |
| Contact: Andrea Pollock | |
| Contact: Colleen Johnston | |
| Principal Investigator: Nicholas Gray | |
| Sub-Investigator: Euan Noble | |
| Sub-Investigator: Kumar Mahadevan | |
| Australia, Tasmania | |
| Royal Hobart Hospital | Completed |
| Hobart, Tasmania, Australia | |
| Australia, Victoria | |
| Royal Melbourne Hospital | Recruiting |
| Melbourne, Victoria, Australia | |
| Contact: Gloria Bruno | |
| Principal Investigator: Eugenia Pedagogos | |
| Sub-Investigator: Peter Hughes | |
| Sub-Investigator: Michael Lian | |
| Sub-Investigator: Kathy Nicholls | |
| Sub-Investigator: Rowan Walker | |
| Monash Medical Centre | Recruiting |
| Melbourne, Victoria, Australia | |
| Contact: Jo Nandkumar | |
| Principal Investigator: Rebecca Pellicano | |
| Sub-Investigator: Fiona Brown | |
| Sub-Investigator: Kevan Polkinghorne | |
| Canada, British Columbia | |
| UBC | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Michael Copland | |
| Contact: Katy Vela | |
| Principal Investigator: Michael Copland | |
| Canada, Ontario | |
| London Health Sciences Centre | Withdrawn |
| London, Ontario, Canada | |
| St Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Jeffrey Perl, MD SM FRCP 416-864-6016 jeff.perl@utoronto.ca | |
| Contact: Niki Dacouris 416-864-6016 DACOURISN@smh.ca | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Christopher Chan | |
| Contact: Margaret McGrath-Chong | |
| Principal Investigator: Christopher Chan | |
| New Zealand | |
| Auckland City Hospital | Recruiting |
| Auckland, New Zealand | |
| Contact: Grace Muyoma | |
| Principal Investigator: Imad Haloob | |
| Dunedin Hospital | Withdrawn |
| Dunedin, New Zealand | |
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Investigators
| Principal Investigator: | Vlado Perkovic, MBBS PhD | The George Institute |
More Information
Additional Information:
No publications provided by The George Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The George Institute |
| ClinicalTrials.gov Identifier: | NCT00649298 History of Changes |
| Other Study ID Numbers: | GI-R-A001- 09 |
| Study First Received: | March 25, 2008 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by The George Institute:
|
End Stage Kidney Disease Health Care Utilisation Health Care Costs Randomized Controlled Trial Clinical Trial Controlled Clinical Trial Clinical Trial, Phase IV Multicenter Study 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 Expenditures Hospitalization Cost Analysis Cardiovascular Diseases Acute Coronary Syndrome Myocardial Infarction Stroke |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Uremia Urologic Diseases Renal Insufficiency, Chronic |
Renal Insufficiency Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013