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A Clinical Trial of IntensiVE Dialysis (ACTIVE)

Primary Purpose

Renal Replacement Therapy, Renal Dialysis, End Stage Kidney Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
haemodialysis
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Replacement Therapy focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Canberra Hospital
  • RPAH/Concord
  • Sydney Adventist Hospital
  • Liverpool Hospital
  • Sydney Dialysis Centre
  • Princess Alexandra Hospital
  • Royal Brisbane Hospital
  • Gold Coast Hospital
  • Nambour General Hospital
  • Royal Hobart Hospital
  • Austin Hospital
  • Monash Medical Centre
  • Royal Melbourne Hospital
  • Sir Charles Gairdner Hospital
  • UBC
  • St Michael's Hospital
  • University Health Network
  • Beijing Hospital of Traditional Chinese Medicine
  • Beijing Tongren Hospital
  • Civil Aviation General Hospital
  • China-Japan Friendship Hospital
  • First Affiliated Hospital of Chinese PLA General Hospital
  • Beijing Hospital
  • Peking University First Hospital
  • Peking University People's Hospital
  • Shenzhen Hospital of Peking University
  • Fourth Hospital Affiliated to Hebei Medical University
  • Shijiazhuang First People's Hospital
  • Third Hospital Affiliated to Hebei Medical University
  • Zhengzhou University affiliated first hospital
  • First Affiliated Hospital of Inner Mongolia, Baotou Medical College
  • Zhongda Hospital, Southeast University
  • Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
  • Dalian Medical affiliated first hospital
  • Shanghai Ruijin Hospital
  • The Chinese PLA Shanghai 85th Hospital
  • The second affiliated hospital of Shanxi Medical University
  • Huaxi Hospital of Sichuan University
  • Auckland City Hospital
  • North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

extended hours

standard hours

Arm Description

24 or more hours per week of hemodialysis

18 or less hours per week of hemodialysis

Outcomes

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.

Secondary Outcome Measures

Survival and cardiovascular analyses
Quality of life and patient acceptability
Safety outcomes
Costs associated with each intervention
Changes in biochemical and haematological parameters

Full Information

First Posted
March 25, 2008
Last Updated
December 1, 2019
Sponsor
The George Institute
Collaborators
National Health and Medical Research Council, Australia, Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00649298
Brief Title
A Clinical Trial of IntensiVE Dialysis
Acronym
ACTIVE
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
National Health and Medical Research Council, Australia, Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extended hours
Arm Type
Experimental
Arm Description
24 or more hours per week of hemodialysis
Arm Title
standard hours
Arm Type
Active Comparator
Arm Description
18 or less hours per week of hemodialysis
Intervention Type
Procedure
Intervention Name(s)
haemodialysis
Other Intervention Name(s)
Dialysis, Renal replacement therapy
Intervention Description
Comparison of different weekly duration of haemodialysis treatment
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Survival and cardiovascular analyses
Time Frame
12 months
Title
Quality of life and patient acceptability
Time Frame
12 months
Title
Safety outcomes
Time Frame
12 months
Title
Costs associated with each intervention
Time Frame
12 months
Title
Changes in biochemical and haematological parameters
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlado Perkovic, MBBS PhD
Organizational Affiliation
The George Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Facility Name
RPAH/Concord
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Sydney Dialysis Centre
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Gold Coast Hospital
City
Gold Coast
State/Province
Queensland
Country
Australia
Facility Name
Nambour General Hospital
City
Nambour
State/Province
Queensland
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
UBC
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Beijing Hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Civil Aviation General Hospital
City
Chaoyang District,
State/Province
Beijing
Country
China
Facility Name
China-Japan Friendship Hospital
City
Chaoyang District
State/Province
Beijing
Country
China
Facility Name
First Affiliated Hospital of Chinese PLA General Hospital
City
Haidian District
State/Province
Beijing
Country
China
Facility Name
Beijing Hospital
City
Xicheng District
State/Province
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Xicheng District
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Xicheng District
State/Province
Beijing
Country
China
Facility Name
Shenzhen Hospital of Peking University
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Fourth Hospital Affiliated to Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Shijiazhuang First People's Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Third Hospital Affiliated to Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Zhengzhou University affiliated first hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
First Affiliated Hospital of Inner Mongolia, Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Dalian Medical affiliated first hospital
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The Chinese PLA Shanghai 85th Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The second affiliated hospital of Shanxi Medical University
City
Taiyuan City
State/Province
Shanxi
Country
China
Facility Name
Huaxi Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
North Shore Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25529309
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.
Results Reference
background
PubMed Identifier
31672793
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.
Results Reference
result
PubMed Identifier
28151412
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.
Results Reference
result
PubMed Identifier
31299919
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.
Results Reference
result
PubMed Identifier
29424935
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.
Results Reference
result
PubMed Identifier
30723975
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.
Results Reference
result
PubMed Identifier
21388319
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.
Results Reference
derived
Links:
URL
http://www.thegeorgeinstitute.org/
Description
The George Institute for International Health seeks to improve global health through undertaking high quality research. Affiliated with the University of Sydney it is an independent, not-for-profit research institute.

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A Clinical Trial of IntensiVE Dialysis

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