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Renal Replacement TherapyPhase 4ACTIVENCT00649298

A Clinical Trial of IntensiVE Dialysis

A Phase 4 study testing haemodialysis in people with Renal Replacement Therapy and Renal Dialysis, run by The George Institute at 40 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
haemodialysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
40 sitesin 4 countries
Study dates
May 2008to Oct 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 4 countries.

40 sites in 4 countries

China21 sites

  • First Affiliated Hospital of Inner Mongolia, Baotou Medical College

    Baotou, Inner Mongolia

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality

  • Fourth Hospital Affiliated to Jilin University (FAW General Hospital)

    Changchun, Jilin

  • China-Japan Friendship Hospital

    Chaoyang District, Beijing Municipality

  • Civil Aviation General Hospital

    Chaoyang District,, Beijing Municipality

  • Huaxi Hospital of Sichuan University

    Chengdu, Sichuan

  • Dalian Medical affiliated first hospital

    Dalian, Liaoning

  • First Affiliated Hospital of Chinese PLA General Hospital

    Haidian District, Beijing Municipality

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality

  • The Chinese PLA Shanghai 85th Hospital

    Shanghai, Shanghai Municipality

  • Shenzhen Hospital of Peking University

    Shenzhen, Guangdong

  • Fourth Hospital Affiliated to Hebei Medical University

    Shijiazhuang, Hebei

  • Shijiazhuang First People's Hospital

    Shijiazhuang, Hebei

  • Third Hospital Affiliated to Hebei Medical University

    Shijiazhuang, Hebei

  • The second affiliated hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Beijing Hospital

    Xicheng District, Beijing Municipality

  • Peking University First Hospital

    Xicheng District, Beijing Municipality

  • Peking University People's Hospital

    Xicheng District, Beijing Municipality

  • Zhengzhou University affiliated first hospital

    Zhengzhou, Henan

Other trials in China

Australia14 sites

  • Princess Alexandra Hospital

    Brisbane, Queensland

  • Royal Brisbane Hospital

    Brisbane, Queensland

  • The Canberra Hospital

    Canberra, Australian Capital Territory

  • Gold Coast Hospital

    Gold Coast, Queensland

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Austin Hospital

    Melbourne, Victoria

  • Monash Medical Centre

    Melbourne, Victoria

  • Royal Melbourne Hospital

    Melbourne, Victoria

  • Nambour General Hospital

    Nambour, Queensland

  • Sir Charles Gairdner Hospital

    Perth, Western Australia

  • RPAH/Concord

    Sydney, New South Wales, 2050

  • Sydney Adventist Hospital

    Sydney, New South Wales, 2076

  • Liverpool Hospital

    Sydney, New South Wales

  • Sydney Dialysis Centre

    Sydney, New South Wales

Other trials in Australia

Canada3 sites

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network

    Toronto, Ontario

  • UBC

    Vancouver, British Columbia

Other trials in Canada

New Zealand2 sites

  • Auckland City Hospital

    Auckland

  • North Shore Hospital

    Auckland

Other trials in New Zealand

About this study

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.

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.

Read the 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.

Being tested
haemodialysis
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
Medical subject headings
Kidney Failure, Chronic, Uremia, Hypertrophy, Left Ventricular, Hypertension, Anemia, Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • haemodialysisProcedure or surgery

    Also called Dialysis, Renal replacement therapy

    Comparison of different weekly duration of haemodialysis treatment

Study groups in NCT00649298
Study groupRoleWhat they receive
extended hoursExperimental24 or more hours per week of hemodialysis
Receives: Procedure: haemodialysis
standard hoursActive comparator18 or less hours per week of hemodialysis
Receives: Procedure: haemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months from randomisation

Secondary outcomes (5)

  1. Survival and cardiovascular analyses

    Measured: 12 months

  2. Quality of life and patient acceptability

    Measured: 12 months

  3. Safety outcomes

    Measured: 12 months

  4. Costs associated with each intervention

    Measured: 12 months

  5. Changes in biochemical and haematological parameters

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00649298
Sponsor's protocol ID
GI-R-A001- 09
Acronym
ACTIVE
Status last verified
Dec 2019
First submitted
25 Mar 2008
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25529309

  • 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.

    PubMed 31672793

  • 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.

    PubMed 28151412

  • 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.

    PubMed 31299919

  • 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.

    PubMed 29424935

  • 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.

    PubMed 30723975

  • 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.

    PubMed 21388319

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing haemodialysis in people with Renal Replacement Therapy and Renal Dialysis, run by The George Institute at 40 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China, Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00649298, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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