ACTIVE: A Clinical Trial of IntensiVE Dialysis

Sponsor

The George Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00649298

Collaborator

National Health and Medical Research Council, Australia (Other), Baxter Healthcare Corporation (Industry)

200

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Replacement Therapy Renal Dialysis End Stage Kidney Disease End Stage Renal Disease Uremia	Procedure: haemodialysis	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: extended hours 24 or more hours per week of hemodialysis	Procedure: haemodialysis Comparison of different weekly duration of haemodialysis treatment Other Names: Dialysis Renal replacement therapy
Active Comparator: standard hours 18 or less hours per week of hemodialysis	Procedure: haemodialysis Comparison of different weekly duration of haemodialysis treatment Other Names: Dialysis Renal replacement therapy

Arm

Intervention/Treatment

Experimental: extended hours

24 or more hours per week of hemodialysis

Procedure: haemodialysis

Comparison of different weekly duration of haemodialysis treatment

Other Names:

Dialysis

Renal replacement therapy

Active Comparator: standard hours

18 or less hours per week of hemodialysis

Procedure: haemodialysis

Comparison of different weekly duration of haemodialysis treatment

Other Names:

Dialysis

Renal replacement therapy

Outcome Measures

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. [12 months from randomisation]

Secondary Outcome Measures

Survival and cardiovascular analyses [12 months]
Quality of life and patient acceptability [12 months]
Safety outcomes [12 months]
Costs associated with each intervention [12 months]
Changes in biochemical and haematological parameters [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Canberra Hospital	Canberra	Australian Capital Territory	Australia
2	RPAH/Concord	Sydney	New South Wales	Australia	2050
3	Sydney Adventist Hospital	Sydney	New South Wales	Australia	2076
4	Liverpool Hospital	Sydney	New South Wales	Australia
5	Sydney Dialysis Centre	Sydney	New South Wales	Australia
6	Princess Alexandra Hospital	Brisbane	Queensland	Australia
7	Royal Brisbane Hospital	Brisbane	Queensland	Australia
8	Gold Coast Hospital	Gold Coast	Queensland	Australia
9	Nambour General Hospital	Nambour	Queensland	Australia
10	Royal Hobart Hospital	Hobart	Tasmania	Australia
11	Austin Hospital	Melbourne	Victoria	Australia
12	Monash Medical Centre	Melbourne	Victoria	Australia
13	Royal Melbourne Hospital	Melbourne	Victoria	Australia
14	Sir Charles Gairdner Hospital	Perth	Western Australia	Australia
15	UBC	Vancouver	British Columbia	Canada
16	St Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
17	University Health Network	Toronto	Ontario	Canada
18	Beijing Hospital of Traditional Chinese Medicine	Beijing	Beijing	China
19	Beijing Tongren Hospital	Beijing	Beijing	China
20	Civil Aviation General Hospital	Chaoyang District,	Beijing	China
21	China-Japan Friendship Hospital	Chaoyang District	Beijing	China
22	First Affiliated Hospital of Chinese PLA General Hospital	Haidian District	Beijing	China
23	Beijing Hospital	Xicheng District	Beijing	China
24	Peking University First Hospital	Xicheng District	Beijing	China
25	Peking University People's Hospital	Xicheng District	Beijing	China
26	Shenzhen Hospital of Peking University	Shenzhen	Guangdong	China
27	Fourth Hospital Affiliated to Hebei Medical University	Shijiazhuang	Hebei	China
28	Shijiazhuang First People's Hospital	Shijiazhuang	Hebei	China
29	Third Hospital Affiliated to Hebei Medical University	Shijiazhuang	Hebei	China
30	Zhengzhou University affiliated first hospital	Zhengzhou	Henan	China
31	First Affiliated Hospital of Inner Mongolia, Baotou Medical College	Baotou	Inner Mongolia	China
32	Zhongda Hospital, Southeast University	Nanjing	Jiangsu	China
33	Fourth Hospital Affiliated to Jilin University (FAW General Hospital)	Changchun	Jilin	China
34	Dalian Medical affiliated first hospital	Dalian	Liaoning	China
35	Shanghai Ruijin Hospital	Shanghai	Shanghai	China
36	The Chinese PLA Shanghai 85th Hospital	Shanghai	Shanghai	China
37	The second affiliated hospital of Shanxi Medical University	Taiyuan City	Shanxi	China
38	Huaxi Hospital of Sichuan University	Chengdu	Sichuan	China
39	Auckland City Hospital	Auckland		New Zealand
40	North Shore Hospital	Auckland		New Zealand