The primary objective is to compare post-transplant outcome after a 6 hour period of NMP immediately prior to transplantation following standard hypothermic machine perfusion (HMP), to outcome after standard HMP alone of 50+ deceased-donor kidneys.…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the primary objective: Estimated glomerular filtration rate (eGFR) at 1
year post-transplant (primary outcome).
Secondary outcome
eGFR at 1, 3 and 6 months, proteinuria, delayed graft function, primary
non-function, biopsy-proven acute rejection, patient and graft survival,
quality of life post-transplant (secondary outcomes). For the secondary
objective: An advanced, multifactorial clinical prediction model for
post-transplant outcome, based on a selection of novel NMP-related biomarkers
and conventional variables.
Background summary
Ex vivo normothermic machine perfusion (NMP) of deceased-donor kidneys prior to
transplantation is a technique that could offer improved preservation of organ
quality compared to hypothermic preservation alone. In addition, NMP might be a
platform for pre-transplant organ assessment, as well as active pharmacological
interventions to enhance organ viability. Nevertheless, to date, none of these
three potential benefits have been convincingly proven. Before NMP can be
considered as a modality for organ preservation, assessment, or resuscitation,
a comparative study needs to be conducted which evaluates its potential merits
compared to the current gold standard cold organ preservation technique.
Study objective
The primary objective is to compare post-transplant outcome after a 6 hour
period of NMP immediately prior to transplantation following standard
hypothermic machine perfusion (HMP), to outcome after standard HMP alone of 50+
deceased-donor kidneys. The secondary objective is to correlate various novel
biomarkers (such as multi-omics, laser speckle imaging and oximetry) measured
during NMP in the context of conventional clinical variables with
post-transplant outcome, in order to establish advanced NMP-based prediction
models.
Study design
Multi-center randomized controlled clinical efficacy study, in which
participants and postoperative caretakers are blinded to the study arm.
Intervention
A period of 6 hours NMP at 37°C immediately prior to transplantation, following
standard hypothermic machine perfusion (HMP) at 0-10°C.
Study burden and risks
Two (UMCG and LUMC) or three (Erasmus MC) additional biopsies of the donor
kidney (before and immediately after it is transplanted), associated with a
minimal, and well manageable, additional bleeding risk at reperfusion of the
kidney, and EuroQuol 6D and MVI-20 quality of life questionnaires, to be
completed by all participants at 1 year post-transplant. The risk of NMP for
the kidney to be transplanted (and hence indirectly for the patient receiving
it), has proven to be negligible in several previous clinical studies. The
benefit of participating in this study could be an improved kidney function for
those patients in the intervention arm, and a better tool to assess the quality
of deceased-donor kidneys in the future, which would eventually benefit all
prospective patients receiving such a renal transplant.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
• Patients receiving their first or second kidney transplant;
• Patients receiving a graft from a >= 50-year-old donor;
• Patients receiving a graft from a DCD or DBD donor;
• Patients receiving a kidney transplant in the UMCG, the Erasmus MC, or the
LUMC;
• Patients receiving a graft stored on HMP;
• Patients >= 18 years of age;
• Patients having provided written informed consent.
Exclusion criteria
• Patients receiving their third or subsequent kidney transplant;
• Patients receiving a graft from a donor < 50 years;
• Patients receiving a graft not stored on HMP;
• Patients unable to understand study information, or unable to provide written
informed consent;
• Patients receiving a kidney transplant in another center than the UMCG,
Erasmus MC, or LUMC;
• Patients receiving a kidney together with one or more other organs from the
same donor;
• Patients receiving a kidney with complex arterial anatomy (3 or more
arteries, which cannot be reconstructed to be connected to the NMP device);
• Patients <18 years of age.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05782543 |
| CCMO | NL86383.042.24 |