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Trial registered on ANZCTR


Registration number
ACTRN12617001532392
Ethics application status
Approved
Date submitted
18/10/2017
Date registered
6/11/2017
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dialysis and Supportive Care in Elderly patients with advanced Renal disease
Scientific title
To determine whether medical management including maintenance dialysis versus medical treatment alone reduces mortality and morbidity in highly co-morbid patients aged over 75 years with stage 5 chronic kidney disease,
Secondary ID [1] 293161 0
None
Universal Trial Number (UTN)
Trial acronym
DISCERN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney disease 305137 0
Condition category
Condition code
Renal and Urogenital 304458 304458 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Medical Treatment and Maintenance Dialysis
Allocation to this study intervention will see the patient receive the usual, appropriate medical treatment for their advanced chronic kidney disease as determined by their treating Renal Physician and integrated team, as per current practices at the Investigational site. Medical treatment includes managing complications such as anaemia, acid/base disturbances, itch, blood pressure and the related comorbid conditions associated with advanced chronic kidney disease. This group will also undergo preparation and entry to a maintenance dialysis program. This treatment component includes preparation of dialysis access, and entry to such a program as clinically indicated by the treating physician and the treating team. This means that some patients in this group may not ever reach the point of entering a dialysis program. The intervention period is up to 3 years, or until a mortality outcome is reached. However, patients will be offered the same clinical care after the study has ended.

Arm 2: Medical Treatment (no Maintenance Dialysis)
Allocation to this study intervention will see the patient receive the usual, appropriate medical treatment for their advanced chronic kidney disease as determined by their treating Renal Physician and integrated team as per current practices of the Investigational site. Medical treatment includes managing complications such as anaemia, acid/base disturbances, itch, blood pressure and the related comorbid conditions associated with advanced chronic kidney disease. This group will receive treatment for any uraemic symptoms using the usual non-dialysis treatments available at that investigating site but will not undergo preparation for entering a dialysis program nor enter such a program unless the treating physician or participant deviates from the study protocol. The intervention period will last up to 3 years, or until a mortality outcome is reached. However, patients will be offered the same clinical care after the study has ended.
Intervention code [1] 299408 0
Treatment: Other
Comparator / control treatment
Comparisons will be made between two treatment arms
Control group
Active

Outcomes
Primary outcome [1] 303700 0
All-cause mortality
Timepoint [1] 303700 0
Within 3 years of randomisation
Secondary outcome [1] 339899 0
Extent of deviation from allocated study treatment arm
Timepoint [1] 339899 0
Over 3 year follow period
Secondary outcome [2] 339900 0
Quality of life, as measured by EQ-5D-3L Health Questionnaire and Satisfaction with Life scale
Timepoint [2] 339900 0
6 months, 12 months, 24 months, 36 months
Secondary outcome [3] 339901 0
Health resource utilisation through total hospital bed days, total cost weights of hospital care and total medical procedures (insertion of dialysis access, interventional radiology procedures, surgical procedures)
Timepoint [3] 339901 0
within 3 years of study follow up period
Secondary outcome [4] 339902 0
Symptom burden of participants, as measured by iPOS-Renal scale questionnaire completed by participants
Timepoint [4] 339902 0
Baseline, 6 months, 12 months, 24 months, 36 months
Secondary outcome [5] 339956 0
Functional Status as assessed by Renal Physician
Timepoint [5] 339956 0
Baseline, 6 months, 12 months, 24 months, 36 months

Eligibility
Key inclusion criteria
1. Aged greater than or equal to 75 years
2. With advanced chronic kidney disease, defined as having an eGFR of less than or equal to 12 ml/min/1.73m2
3. Is expected by their treating physician to meet clinical criteria for entry to a maintenance dialysis program within the next 24 months.
4. Has satisfied the treating unit’s policies relating to education regarding end stage kidney disease treatment options
5. The treating physician caring for the participant has equipoise about the balance of risk and benefit for the participant should they enter either treatment arm of the study.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treating physician considers it unlikely that the participant will adhere to allocated study treatment
2. Participant unable to understand the implications of both of the study treatment arms for their future care
3. The treating physician expects that the participant will not survive 3 months beyond study randomisation

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)
Central randomisation by web-based data management system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a computer-generated algorithm employing randomly permuted blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome will be analysed using a comparison of two independent proportions using a Chai-squared statistic. Secondary outcomes will be analysed according to the nature of the underlying data, utilising parametric and non-parametric tests and their appropriate analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2020
Actual
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 9203 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 14800 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 17857 0
2139 - Concord
Recruitment postcode(s) [2] 28050 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297788 0
Other Collaborative groups
Name [1] 297788 0
The George Institute for Global Health
Country [1] 297788 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 5, 1 King Street, Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 296828 0
None
Name [1] 296828 0
Address [1] 296828 0
Country [1] 296828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298847 0
Sydney Local Health District Human Research Ethics Committee (CRGH Zone)
Ethics committee address [1] 298847 0
Concord Hospital
Research and Governance Office
Building 20, Ground Floor
Hospital Rd, Concord NSW 2037
Ethics committee country [1] 298847 0
Australia
Date submitted for ethics approval [1] 298847 0
24/10/2017
Approval date [1] 298847 0
18/01/2018
Ethics approval number [1] 298847 0

Summary
Brief summary
The burden of end stage kidney disease is growing globally. Much of this growth since the turn of the century has been in elderly patients, a group in whom the outcomes from both dialysis and non-dialysis treatments are poor. Optimal therapy for these older patients with end stage kidney disease is not clear and practice varies widely.
Recent literature shows high mortality rates in older patients receiving dialysis, with an average mortality of 27% in the first year. Data on the outcomes from non-dialysis treatment, usually referred to as supportive care, is much less clear. This is because:
• There are no registries of patients receiving supporting care
• It is difficult to define a clear start-in point for supportive care, as opposed to dialysis initiation
• Dialysis patient groups compared to supportive care patients have large differences in co-morbidities
• There is crossover between the two patient pathways
The only effective way to better understand the effects of the dialysis and the supportive care treatment approaches is to randomly apply the treatments in a clinical trial. This approach allows the issues of lead-time bias, residual confounding and cross-over to be eliminated or managed, thereby producing findings of the highest clinical and scientific value.
It is the view of the investigators of the DISCERN Trial that, where clinicians and patients have equipoise around the relative benefits and risks of dialysis and supportive care, to randomly allocate patients to either of these treatment approaches is an appropriate and ethical approach. In a setting for scarce healthcare resources, understanding this balance arising from a resource-intensive treatment such as dialysis is the appropriate path to guide resource allocation.
Objectives: The primary null hypothesis of the DISCERN study is that, in highly co-morbid patients aged over 75 years with stage 5 chronic kidney disease, medical management including maintenance dialysis compared to medical treatment alone is associated with no differences in the outcome of mortality. Secondary null hypotheses will examine the effect of the same comparison upon the outcomes of quality of life, burden of hospitalisation and cost-effectiveness.
Study Design: The DISCERN study is a randomised, controlled trial with blinding of outcome assessment. Participants will be randomised on a 1:1 basis to the two study arms: Medical treatment with maintenance dialysis, OR medical treatment (with no maintenance dialysis).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78430 0
A/Prof Martin Gallagher
Address 78430 0
The George Institute for Global Health
Level 5, 1 King Street,
Newtown NSW 2042
Country 78430 0
Australia
Phone 78430 0
+612 8052 4552
Fax 78430 0
+612 8088 6088
Email 78430 0
[email protected]
Contact person for public queries
Name 78431 0
Sarah Coggan
Address 78431 0
The George Institute for Global Health
Level 5, 1 King Street,
Newtown NSW 2042
Country 78431 0
Australia
Phone 78431 0
+612 8052 4566
Fax 78431 0
+612 8088 6088
Email 78431 0
[email protected]
Contact person for scientific queries
Name 78432 0
Martin Gallagher
Address 78432 0
The George Institute for Global Health
Level 5, 1 King Street,
Newtown NSW 2042
Country 78432 0
Australia
Phone 78432 0
+612 8052 4566
Fax 78432 0
+612 8088 6088
Email 78432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small participant cohort hence the risk of breaching confidentiality of participants is too high.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4677Study protocol  [email protected]
4678Informed consent form  [email protected]
4679Ethical approval  [email protected]



Results publications and other study-related documents

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