A Clinical Trial of IntensiVE Dialysis

NCT ID: NCT00649298

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Renal Replacement Therapy Renal Dialysis End Stage Kidney Disease End Stage Renal Disease Uremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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extended hours

24 or more hours per week of hemodialysis

Group Type EXPERIMENTAL

haemodialysis

Intervention Type PROCEDURE

Comparison of different weekly duration of haemodialysis treatment

standard hours

18 or less hours per week of hemodialysis

Group Type ACTIVE_COMPARATOR

haemodialysis

Intervention Type PROCEDURE

Comparison of different weekly duration of haemodialysis treatment

Interventions

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haemodialysis

Comparison of different weekly duration of haemodialysis treatment

Intervention Type PROCEDURE

Other Intervention Names

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Dialysis Renal replacement therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

The George Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vlado Perkovic, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Locations

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The Canberra Hospital

Canberra, Australian Capital Territory, Australia

Site Status

RPAH/Concord

Sydney, New South Wales, Australia

Site Status

Sydney Adventist Hospital

Sydney, New South Wales, Australia

Site Status

Liverpool Hospital

Sydney, New South Wales, Australia

Site Status

Sydney Dialysis Centre

Sydney, New South Wales, Australia

Site Status

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status

Royal Brisbane Hospital

Brisbane, Queensland, Australia

Site Status

Gold Coast Hospital

Gold Coast, Queensland, Australia

Site Status

Nambour General Hospital

Nambour, Queensland, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Austin Hospital

Melbourne, Victoria, Australia

Site Status

Monash Medical Centre

Melbourne, Victoria, Australia

Site Status

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Site Status

UBC

Vancouver, British Columbia, Canada

Site Status

St Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Site Status

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status

Civil Aviation General Hospital

Chaoyang District,, Beijing Municipality, China

Site Status

China-Japan Friendship Hospital

Chaoyang District, Beijing Municipality, China

Site Status

First Affiliated Hospital of Chinese PLA General Hospital

Haidian District, Beijing Municipality, China

Site Status

Beijing Hospital

Xicheng District, Beijing Municipality, China

Site Status

Peking University First Hospital

Xicheng District, Beijing Municipality, China

Site Status

Peking University People's Hospital

Xicheng District, Beijing Municipality, China

Site Status

Shenzhen Hospital of Peking University

Shenzhen, Guangdong, China

Site Status

Fourth Hospital Affiliated to Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Shijiazhuang First People's Hospital

Shijiazhuang, Hebei, China

Site Status

Third Hospital Affiliated to Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Zhengzhou University affiliated first hospital

Zhengzhou, Henan, China

Site Status

First Affiliated Hospital of Inner Mongolia, Baotou Medical College

Baotou, Inner Mongolia, China

Site Status

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status

Fourth Hospital Affiliated to Jilin University (FAW General Hospital)

Changchun, Jilin, China

Site Status

Dalian Medical affiliated first hospital

Dalian, Liaoning, China

Site Status

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

The Chinese PLA Shanghai 85th Hospital

Shanghai, Shanghai Municipality, China

Site Status

The second affiliated hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

Huaxi Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

North Shore Hospital

Auckland, , New Zealand

Site Status

Countries

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Australia Canada China New Zealand

References

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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.

Reference Type BACKGROUND
PMID: 25529309 (View on PubMed)

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.

Reference Type RESULT
PMID: 31672793 (View on PubMed)

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.

Reference Type RESULT
PMID: 28151412 (View on PubMed)

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.

Reference Type RESULT
PMID: 31299919 (View on PubMed)

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.

Reference Type RESULT
PMID: 29424935 (View on PubMed)

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.

Reference Type RESULT
PMID: 30723975 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21388319 (View on PubMed)

Other Identifiers

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GI-R-A001- 09

Identifier Type: -

Identifier Source: org_study_id

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