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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00649298




Registration number
NCT00649298
Ethics application status
Date submitted
25/03/2008
Date registered
1/04/2008
Date last updated
24/06/2015

Titles & IDs
Public title
A Clinical Trial of IntensiVE Dialysis
Scientific 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.
Secondary ID [1] 0 0
GI-R-A001- 09
Universal Trial Number (UTN)
Trial acronym
ACTIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Replacement Therapy 0 0
Renal Dialysis 0 0
End Stage Kidney Disease 0 0
End Stage Renal Disease 0 0
Uremia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - haemodialysis

Experimental: extended hours - 24 or more hours per week of hemodialysis

Active Comparator: standard hours - 18 or less hours per week of hemodialysis


Treatment: Surgery: haemodialysis
Comparison of different weekly duration of haemodialysis treatment

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months from randomisation
Secondary outcome [1] 0 0
Survival and cardiovascular analyses
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Quality of life and patient acceptability
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Safety outcomes
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Costs associated with each intervention
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Changes in biochemical and haematological parameters
Timepoint [5] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
RPAH/Concord - Sydney
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [4] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [5] 0 0
Sydney Dialysis Centre - Sydney
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [8] 0 0
Gold Coast Hospital - Gold Coast
Recruitment hospital [9] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Austin Hospital - Melbourne
Recruitment hospital [12] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [13] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [14] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2076 - Sydney
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Gold Coast
Recruitment postcode(s) [7] 0 0
- Nambour
Recruitment postcode(s) [8] 0 0
- Hobart
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Guangdong
Country [5] 0 0
China
State/province [5] 0 0
Hebei
Country [6] 0 0
China
State/province [6] 0 0
Henan
Country [7] 0 0
China
State/province [7] 0 0
Inner Mongolia
Country [8] 0 0
China
State/province [8] 0 0
Jiangsu
Country [9] 0 0
China
State/province [9] 0 0
Jilin
Country [10] 0 0
China
State/province [10] 0 0
Liaoning
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
China
State/province [12] 0 0
Shanxi
Country [13] 0 0
China
State/province [13] 0 0
Sichuan
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Baxter Healthcare Corporation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00649298
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vlado Perkovic, MBBS PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications