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Trial registered on ANZCTR


Registration number
ACTRN12620000036910p
Ethics application status
Submitted, not yet approved
Date submitted
20/11/2019
Date registered
21/01/2020
Date last updated
4/02/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 clinical trial of Normothermic EX vivo perfusion prior to Transplantation of the Kidney
Scientific title
Phase 1 clinical trial of normothermic ex vivo perfusion prior to transplantation of the Kidney, to assess feasibility, effects on delayed graft function, and graft outcomes
Secondary ID [1] 299865 0
NEXT-Kidney
Universal Trial Number (UTN)
Nil known
Trial acronym
NEXT-Kidney
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Renal failure
315276 0
Condition category
Condition code
Renal and Urogenital 313573 313573 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kidneys from donation after circulatory death donors (DCD) deemed suitable for clinical transplantation will be considered for this phase 1 trial. if the adult recipients provide consent, Kidneys will be perfused using a TGA approved "Kidney Assist," normothermic machine perfusion device. A minimum of one hour perfusion time will be employed directly prior to transplantation. 4 hours will be the maximum perfusion time. Blood, heparinised and oxygenated is the perfusate and requires to be removed using standard cold preservation solution, at the end of the perfusion period, prior to implantation. This normothermic machine perfusion intervention will be performed in the operating theatre by the principal investigator and transplant team, all of whom have completed training in the use of the Kidney assist device. In addition the PI has supervised a PhD student who has utilised this technology with discarded human kidneys, prior to this clinical trial.
Intervention code [1] 316130 0
Treatment: Devices
Comparator / control treatment
Although this is primarily a feasibility study using 10-20 DCD kidneys, graft outcomes will be also be compred to two separate control groups:
(i) The contralateral (2nd) kidney from the same donor, which will not be machine perfused, and
(ii) Historical data sourced from ANZDATA for the preceding 5 years (01/01/2015-31/12/2020).
Control group
Historical

Outcomes
Primary outcome [1] 322029 0
Feasibility/implementation of normothermic machine perfusion of deceased donor kidneys prior to transplantation within the Australian setting.
Timepoint [1] 322029 0
Up to 6 months post-transplant.
Secondary outcome [1] 377077 0
Delayed graft function defined as the need for dialysis within the first 7 days. This is assessed on clinical and biochemical grounds ie serum potassium, urea and creatinine levels, as well as clinical fluid overload.
Timepoint [1] 377077 0
Need for dialysis within the first 7 post operative days
Secondary outcome [2] 378902 0
eGFR is assessed using CKD-EPI calculation based on gender, age and creatinine. Based on age, sex and serum biochemistry
Timepoint [2] 378902 0
1 month, 6 months and 1 year post transplant
Secondary outcome [3] 378903 0
Graft survival
Timepoint [3] 378903 0
1, 6, and 12 months post-transplant
Secondary outcome [4] 378904 0
Patient survival
Timepoint [4] 378904 0
1, 6, and 12 months post-transplant

Eligibility
Key inclusion criteria
Consenting adult recipients aged over 18 years who have been allocated a DCD kidney for Transplantation at Westmead Hospital NSW.

They must be able to understand the intervention which is being performed on the kidney, prior to it being transplanted into themselves and the potential complications and be able to give consent freely.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No paediatric recipient will be included in this trial. Patients who have either mental health or communication issues, such that they cannot consent or understand the trial will also be excluded. However both of these are usually a contraindication to transplantation, if they are unable to comply with standard post transplant care. Furthermore, patients undergoing their 3rd or more transplant or multi-organ transplantation will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The other kidney from the deceased donor, not perfused acts as the control, with outcome data being available through ANZDATA. Furthermore, historical data obtained from ANZDATA (2015-2020) will also be used as a second control.
Currently DCD kidneys have approximately 50% incidence of DGF within Australia.
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is primarily a feasibility study to ensure safety with this technology, not previously used within Australia. Provided the small series shows no added complications to the recipients, a larger prospective RCT will be required to confirm statistical benefits in terms of incidence of DGF, allograft survival and eGFR at 1 year.
However this phase 1 trial data will be used and outcomes compared with both historical control cohorts, as well as the non perfused kidney from each deceased organ donor. Outcomes that will be compared will include DGF rate, and eGFR, graft, and patient survivals at 1, 6, and 12 months post-transplantation.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 15274 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 28584 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304326 0
Charities/Societies/Foundations
Name [1] 304326 0
John Loewenthal project grant RACS
Address [1] 304326 0
RACS
College of Surgeons Gardens
250/290 Spring st
East Melbourne
VIC 3002
Country [1] 304326 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Royal Australasian College of Surgeons
Address
250/290 Spring St East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 304572 0
None
Name [1] 304572 0
Address [1] 304572 0
Country [1] 304572 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304778 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304778 0
Westmead Hospital
Westmead
Darcy Rd NSW 2145
Ethics committee country [1] 304778 0
Australia
Date submitted for ethics approval [1] 304778 0
15/11/2019
Approval date [1] 304778 0
Ethics approval number [1] 304778 0
Ethics committee name [2] 305145 0
Bellberry Limited
Ethics committee address [2] 305145 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [2] 305145 0
Australia
Date submitted for ethics approval [2] 305145 0
11/01/2020
Approval date [2] 305145 0
Ethics approval number [2] 305145 0

Summary
Brief summary
This is a feasibility study of normothermic machine perfusion technology in human DCD kidneys deemed suitable for transplantation. If preliminary results are encouraging a larger prospective RCT will be required to confirm whether this technology improves Kidney transplant outcomes in the clinical setting. Experimental data and early non randomised clinical studies from Europe appear to show a significant benefit, by reducing the need for post transplant dialysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98166 0
Prof Henry Pleass
Address 98166 0
Dept of Surgery
Westmead Hospital
Darcy Rd
Westmead, NSW 2145
Country 98166 0
Australia
Phone 98166 0
+61 2 88905555
Fax 98166 0
Email 98166 0
henry.pleass@sydney.edu.au
Contact person for public queries
Name 98167 0
Dr Ahmer Hameed
Address 98167 0
Department of Surgery
Westmead Hospital
Corner Darcy road and Hawkesbury Rd
Westmead NSW 2145

Country 98167 0
Australia
Phone 98167 0
+61 2 88905555
Fax 98167 0
Email 98167 0
henry.pleass@sydney.edu.au
Contact person for scientific queries
Name 98168 0
Dr Ahmer Hameed
Address 98168 0
Department of Surgery
Westmead Hospital
Corner Darcy road and Hawkesbury Rd
Westmead NSW 2145

Country 98168 0
Australia
Phone 98168 0
+61 2 88905555
Fax 98168 0
Email 98168 0
henry.pleass@sydney.edu.au

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 other documents available
Summary results
No Results