Status:
COMPLETED
Better Evidence for Selecting Transplant Fluids
Lead Sponsor:
The University of Queensland
Collaborating Sponsors:
Australian Government Department of Health and Ageing
Health Research Council, New Zealand
Conditions:
End Stage Kidney Disease
Delayed Graft Function
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However som...
Detailed Description
End-stage kidney disease is a significant public health problem worldwide, and its treatment imposes a high healthcare burden and cost. Kidney transplantation is considered the best treatment for ESKD...
Eligibility Criteria
Inclusion
- Adult or child with End-Stage Kidney Disease, of any cause, on maintenance dialysis, or who has pre-dialysis stage 5 chronic kidney disease with an estimated Glomerular Filtration Rate of \<15 mL/min/1.73m2, AND
- Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor within 24 hours, AND
- Written informed consent, or consent given by their parent or guardian (if age \<18), or other authorised person
Exclusion
- Planned live donor kidney transplant (except where this is cancelled in favour or transplantation from a deceased donor)
- Planned multi-organ transplant (dual or en-bloc kidney transplants are not excluded)
- Children of weight \<20 kg, or a child that the treating physician believes should not be included in a study of blinded fluids due to their small body size
- Known hypersensitivity to the trial fluid preparations or packaging
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
808 Patients enrolled
Trial Details
Trial ID
NCT03829488
Start Date
January 26 2018
End Date
May 3 2022
Last Update
October 15 2024
Active Locations (18)
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1
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
2
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
3
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
4
The Children's Hospital at Westmead
Sydney, New South Wales, Australia, 2145