Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000521426p
Ethics application status
Submitted, not yet approved
Date submitted
5/05/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Short versus long continuous oxygenated hypothermic machine perfusion (HMP) prior to kidney transplantation
Scientific title
The efficacy of short versus prolonged continuous oxygenated hypothermic machine perfusion (HMP) prior to deceased donor kidney transplantation on delayed graft function
Secondary ID [1] 314357 0
None
Universal Trial Number (UTN)
Trial acronym
7n11 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 337349 0
Condition category
Condition code
Renal and Urogenital 333732 333732 0 0
Kidney disease
Surgery 333733 333733 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous oxygenated hypothermic machine perfusion (HMP) of the kidney prior to transplantation - long duration
Patients will be eligible for this arm of the study if their kidney transplant is anticipated to be reperfused after 1900 hours on the same day - in this case it will be left on HMP until 0800 the following day
This will be performed using the Kidney Assist Transporter Device (XVIVO)
The temperature will be maintained between 1-5 degrees C
The perfusion pressure will be set to 25 mmHg
Oxygen (100%) will be delivered at 100 ml/min
Perfusion will be commenced at the organ retrieval centre and continued until the patient is ready for transplant, and their iliac vessels have been dissected out
The retrieval surgeon will connect the kidney to the perfusion device, and along with a transplant perfusionist, will monitor it remotely during the period of perfusion
Device analytics will be accessed to obtain a summary of the overall perfusion record, including perfusion pressures and resistance
Intervention code [1] 330974 0
Treatment: Devices
Comparator / control treatment
Continuous oxygenated hypothermic machine perfusion (HMP) of the kidney prior to transplantation - short duration (< 12 hours)
Patients will be eligible for this arm of the study if their kidney transplant is anticipated to be reperfused before 1900 hours on the same day - in this case it will be left on HMP until ready for transplantation on the same day
This will be performed using the Kidney Assist Transporter Device (XVIVO)
The temperature will be maintained between 1-5 degrees C
The perfusion pressure will be set to 25 mmHg
Oxygen (100%) will be delivered at 100 ml/min
Perfusion will be commenced at the organ retrieval centre and continued until the patient is ready for transplant, and their iliac vessels have been dissected out
The retrieval surgeon will connect the kidney to the perfusion device, and along with a transplant perfusionist, will monitor it remotely during the period of perfusion
Device analytics will be accessed to obtain a summary of the overall perfusion record, including perfusion pressures and resistance
Control group
Active

Outcomes
Primary outcome [1] 341328 0
Delayed graft function (DGF), as defined by the requirement for dialysis in the first week post-transplantation
Timepoint [1] 341328 0
7 days post-transplantation
Secondary outcome [1] 447124 0
Duration of delayed graft function in days
Timepoint [1] 447124 0
Up to 3 months post-transplantation
Secondary outcome [2] 447125 0
Hospital length of stay
Timepoint [2] 447125 0
At time of initial hospital discharge post-transplant
Secondary outcome [3] 447126 0
Biopsy-proven acute rejection
Timepoint [3] 447126 0
Within 1st month post-transplantation
Secondary outcome [4] 447127 0
Creatinine reduction ratio on post-operative day 2 and post-operative day 5, calculated as follows: Creatinine day 1 = Serum Creatinine day 2 divided by Serum Creatinine day 1 Creatinine pre-transplant = Serum Creatinine day 5 divided by Serum Creatinine pre-transplant
Timepoint [4] 447127 0
Day 2 and 5 post-transplantation
Secondary outcome [5] 447128 0
Serum creatinine at 1, 3, 6, and 12 months post-transplantation
Timepoint [5] 447128 0
1, 3, 6, and 12 months post-transplantation
Secondary outcome [6] 447129 0
Patient survival at 12 months
Timepoint [6] 447129 0
12 months post-transplantation
Secondary outcome [7] 447130 0
Graft survival at 12 months
Timepoint [7] 447130 0
12 months post-transplantation
Secondary outcome [8] 447131 0
Primary non-function
Timepoint [8] 447131 0
Up to 3 months post-transplantation
Secondary outcome [9] 447136 0
Complications related to hypothermic machine perfusion
Timepoint [9] 447136 0
During entire period of hypothermic machine perfusion
Secondary outcome [10] 447140 0
Peri-operative complications - take-back to theatre
Timepoint [10] 447140 0
Up to 1 month post-transplantation
Secondary outcome [11] 447571 0
Serum eGFR at 1, 3, 6, and 12 months post-transplantation
Timepoint [11] 447571 0
1, 3, 6, and 12 months post-transplantation
Secondary outcome [12] 447573 0
Record yes or no if - arterial or venous thrombosis
Timepoint [12] 447573 0
Any time within 1st month post transplantation
Secondary outcome [13] 447574 0
Record yes or no if - urologic complications (composite of urine leak, urinary stenosis, and/or ureter reimplantation)
Timepoint [13] 447574 0
Up to 1 month post-transplantation

Eligibility
Key inclusion criteria
o All deceased donor kidneys (DCD or DBD) that are deemed suitable for transplantation
o All suitable recipients who are more than or equal to 18 years, and undergoing their first or second kidney transplant
o Organ donation in NSW, with involvement of the Westmead retrieval team
o All recipients who are able to provide informed consent
o In a paired kidney donation (i.e. both kidneys from the same donor are allocated for transplantation at Westmead), only a single kidney will be taken for HMP, and the contralateral kidney will undergo standard cold static storage (CS) alone prior to transplantation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Multi-organ transplantation (e.g. simultaneous pancreas kidney transplantation, or dual kidney transplantation)
o Unable to place kidney on HMP device for any reason (e.g. technically unable to cannulate without significant leakage in system)

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)
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2025
Actual
Date of last participant enrolment
Anticipated
9/08/2027
Actual
Date of last data collection
Anticipated
14/08/2028
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27878 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 44074 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 318877 0
Hospital
Name [1] 318877 0
Westmead Hospital
Country [1] 318877 0
Australia
Funding source category [2] 318882 0
Hospital
Name [2] 318882 0
Westmead Hospital Foundation
Country [2] 318882 0
Australia
Primary sponsor type
Hospital
Name
Western Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321348 0
None
Name [1] 321348 0
None
Address [1] 321348 0
Country [1] 321348 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317491 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 317491 0
Ethics committee country [1] 317491 0
Australia
Date submitted for ethics approval [1] 317491 0
05/05/2025
Approval date [1] 317491 0
Ethics approval number [1] 317491 0

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

Contacts
Principal investigator
Name 141222 0
Dr Ahmer Hameed
Address 141222 0
Westmead Hospital, Hawkesbury Rd Westmead, NSW 2145
Country 141222 0
Australia
Phone 141222 0
+61 2 8890 6962
Fax 141222 0
Email 141222 0
[email protected]
Contact person for public queries
Name 141223 0
Ahmer Hameed
Address 141223 0
Westmead Hospital, Hawkesbury Rd Westmead, NSW 2145
Country 141223 0
Australia
Phone 141223 0
+61 2 8890 5555
Fax 141223 0
Email 141223 0
[email protected]
Contact person for scientific queries
Name 141224 0
Ahmer Hameed
Address 141224 0
Westmead Hospital, Hawkesbury Rd Westmead, NSW 2145
Country 141224 0
Australia
Phone 141224 0
+61 2 8890 5555
Fax 141224 0
Email 141224 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.