ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

DISCERN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

End Stage Kidney disease

Condition category

Condition code

Renal and Urogenital

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]

Treatment: Other

Comparator / control treatment

Comparisons will be made between two treatment arms

Control group

Active

Outcomes

Primary outcome [1]

All-cause mortality

Timepoint [1]

Within 3 years of randomisation

Secondary outcome [1]

Extent of deviation from allocated study treatment arm

Timepoint [1]

Over 3 year follow period

Secondary outcome [2]

Quality of life, as measured by EQ-5D-3L Health Questionnaire and Satisfaction with Life scale

Timepoint [2]

6 months, 12 months, 24 months, 36 months

Secondary outcome [3]

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]

within 3 years of study follow up period

Secondary outcome [4]

Symptom burden of participants, as measured by iPOS-Renal scale questionnaire completed by participants

Timepoint [4]

Baseline, 6 months, 12 months, 24 months, 36 months

Secondary outcome [5]

Functional Status as assessed by Renal Physician

Timepoint [5]

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?

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]

Concord Repatriation Hospital - Concord

Recruitment hospital [2]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2139 - Concord

Recruitment postcode(s) [2]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

The George Institute for Global Health

Address [1]

Level 5, 1 King Street, Newtown NSW 2042

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee (CRGH Zone)

Ethics committee address [1]

Concord Hospital
Research and Governance Office
Building 20, Ground Floor
Hospital Rd, Concord NSW 2037

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/10/2017

Approval date [1]

18/01/2018

Ethics approval number [1]

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

A/Prof Martin Gallagher

Address

The George Institute for Global Health
Level 5, 1 King Street,
Newtown NSW 2042

Country

Australia

Phone

+612 8052 4552

Fax

+612 8088 6088

mgallagher@georginstitute.org.au

Contact person for public queries

Name

Sarah Coggan

Address

The George Institute for Global Health
Level 5, 1 King Street,
Newtown NSW 2042

Country

Australia

Phone

+612 8052 4566

Fax

+612 8088 6088

scoggan@georgeinstitute.org.au

Contact person for scientific queries

Name

Martin Gallagher

Address

The George Institute for Global Health
Level 5, 1 King Street,
Newtown NSW 2042

Country

Australia

Phone

+612 8052 4566

Fax

+612 8088 6088

mgallagher@georgeinstitute.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
4677	Study protocol	mgallagher@georgeinstitute.org.au
4678	Informed consent form	scoggan@georgeinstitute.org.au
4679	Ethical approval	scoggan@georgeinstitute.org.au

Results publications and other study-related documents

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