A Clinical Trial of IntensiVE Dialysis

End Stage Renal Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649298
• Other study ID #: GI-R-A001- 09
• Status: Completed
• Phase: Phase 4
• Start date: May 2008
• Est. completion date: October 2014

Study information

• Verified date: December 2019
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Dialysis
• Renal Replacement Therapy
• Uremia

Intervention

Procedure:
• haemodialysis
Comparison of different weekly duration of haemodialysis treatment

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane Hospital	Brisbane	Queensland
Australia	The Canberra Hospital	Canberra	Australian Capital Territory
Australia	Gold Coast Hospital	Gold Coast	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Austin Hospital	Melbourne	Victoria
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	Nambour General Hospital	Nambour	Queensland
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	RPAH/Concord	Sydney	New South Wales
Australia	Sydney Adventist Hospital	Sydney	New South Wales
Australia	Sydney Dialysis Centre	Sydney	New South Wales
Canada	St Michael's Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	UBC	Vancouver	British Columbia
China	First Affiliated Hospital of Inner Mongolia, Baotou Medical College	Baotou	Inner Mongolia
China	Beijing Hospital of Traditional Chinese Medicine	Beijing	Beijing
China	Beijing Tongren Hospital	Beijing	Beijing
China	Fourth Hospital Affiliated to Jilin University (FAW General Hospital)	Changchun	Jilin
China	China-Japan Friendship Hospital	Chaoyang District	Beijing
China	Civil Aviation General Hospital	Chaoyang District,	Beijing
China	Huaxi Hospital of Sichuan University	Chengdu	Sichuan
China	Dalian Medical affiliated first hospital	Dalian	Liaoning
China	First Affiliated Hospital of Chinese PLA General Hospital	Haidian District	Beijing
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	The Chinese PLA Shanghai 85th Hospital	Shanghai	Shanghai
China	Shenzhen Hospital of Peking University	Shenzhen	Guangdong
China	Fourth Hospital Affiliated to Hebei Medical University	Shijiazhuang	Hebei
China	Shijiazhuang First People's Hospital	Shijiazhuang	Hebei
China	Third Hospital Affiliated to Hebei Medical University	Shijiazhuang	Hebei
China	The second affiliated hospital of Shanxi Medical University	Taiyuan City	Shanxi
China	Beijing Hospital	Xicheng District	Beijing
China	Peking University First Hospital	Xicheng District	Beijing
China	Peking University People's Hospital	Xicheng District	Beijing
China	Zhengzhou University affiliated first hospital	Zhengzhou	Henan
New Zealand	Auckland City Hospital	Auckland
New Zealand	North Shore Hospital	Auckland

Sponsors (3)

Lead Sponsor	Collaborator
The George Institute	Baxter Healthcare Corporation, National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

Australia,  Canada,  China,  New Zealand, 

References & Publications (6)

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 (Carl — View 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 Qual — View 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. — View 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 — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival and cardiovascular analyses		12 months
Secondary	Quality of life and patient acceptability		12 months
Secondary	Safety outcomes		12 months
Secondary	Costs associated with each intervention		12 months
Secondary	Changes in biochemical and haematological parameters		12 months

External Links

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