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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02675569




Registration number
NCT02675569
Ethics application status
Date submitted
26/01/2016
Date registered
5/02/2016

Titles & IDs
Public title
ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis
Scientific title
ACCESS HD Pilot: A Randomized Trial Comparing Catheters to Fistulas in Elderly patientS Starting HemoDialysis
Secondary ID [1] 0 0
REB14-1670
Universal Trial Number (UTN)
Trial acronym
ACCESS HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Active comparator: Catheter - Catheter is a method of vascular access for hemodialysis. It consists of a long, thin plastic tube and may be either tunnelled or non-tunnelled.

Experimental: Fistula - Fistula is a type of vascular access strategy for hemodialysis in which a direct connection of an artery to a vein is created. It is intended to provide an access with good blood flow that can last for decades.


Treatment: Surgery: Catheter
A method of vascular access for hemodialysis that all participants will have in place prior to randomization.

Treatment: Surgery: Fistula
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility; proportion of eligible people who are randomized (at least 25%)
Timepoint [1] 0 0
42 months
Primary outcome [2] 0 0
Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%)
Timepoint [2] 0 0
42 months
Secondary outcome [1] 0 0
Descriptive; reasons for exclusion of all screened participants (feasibility)
Timepoint [1] 0 0
42 months
Secondary outcome [2] 0 0
Descriptive; reasons that people decline to participate (feasibility)
Timepoint [2] 0 0
42 months
Secondary outcome [3] 0 0
Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility)
Timepoint [3] 0 0
42 months
Secondary outcome [4] 0 0
Descriptive; reasons for delayed access to fistula surgery (feasibility)
Timepoint [4] 0 0
42 months
Secondary outcome [5] 0 0
Safety; expected procedure-related outcomes for both catheter and fistula treatment strategies that occur within 7 days of the execution of any access related intervention
Timepoint [5] 0 0
7 days
Secondary outcome [6] 0 0
Number of drop-ins
Timepoint [6] 0 0
42 months
Secondary outcome [7] 0 0
Number of drop-outs
Timepoint [7] 0 0
42 months

Eligibility
Key inclusion criteria
1. Adult patients age = 55; (AUS sites : adult patients age = 65);
2. a). Started hemodialysis using a tunnelled, or non-tunnelled catheter for vascular access AND = 1 previously unsuccessful fistula attempt; OR b).Changing over from peritoneal dialysis AND no functioning arteriovenous fistula available at HD start;
3. Treated with hemodialysis for 365 days or less at the time of consent (374 days or less at the time of randomization);
4. Clinically and cognitively stable (able to provide consent within 365 days of hemodialysis start);
5. Hemodialysis is the intended modality of treatment;
6. End-stage (permanent) kidney failure unlikely to recover kidney function according to the attending nephrologist;
7. Eligible for a fistula attempt as determined by the local multidisciplinary access team;
8. Planning to remain in the current dialysis center/service for at least 6 months;
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Started hemodialysis with a fistula or have a patent fistula already in place or had >1 unsuccessful attempt; (AUS sites: or previously functioning fistula no longer working);
2. . Has had a prior arteriovenous graft creation;
3. Imminent transplant planned (within 6 months);
4. Metastatic malignancy or other condition associated with a life expectancy of less than 6 months, in the opinion of the attending nephrologist;

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Illawarra Shoalhaven Local Health District (ISLHD) - Wollongong
Recruitment hospital [3] 0 0
Sunshine Coast Hospital and Health Service (SCHHS) - Birtinya
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Newfoundland and Labrador
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University of Calgary
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Applied Health Research Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The George Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rob Quinn, PhD
Address 0 0
University of Calgary
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sorcha Mulligan
Address 0 0
Country 0 0
Phone 0 0
416-360-4000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02675569