End Stage Renal Disease
Conditions
Keywords
normothermic machine perfusion, renal transplantation, kidney transplantation
Brief summary
The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.
Detailed description
Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient with a widening gap between supply and demand. Nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. Furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. Increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool. Using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. Furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. There is a dire need for tools to aid in decision making and reduce this uncertainty. Biomarkers predictive of graft regeneration are lacking. Samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.
Interventions
PROCEDUREProlonged normothermic machine perfusion
First, a cohort of DCD kidneys (n=6) will be subjected to 1 hour of NMP and subsequently transplanted \[NMP1\]. Before extending the duration, secondary endpoints will be evaluated. Thereafter, the duration of NMP will be prolonged to 3 hours (n=6) \[PNMP3\] and consequently 6 hours (n=6) \[PNMP6\].
Sponsors
Leiden University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing 1st or 2nd kidney transplant * Patients undergoing a kidney transplantation from DCD Maastricht III & V * Transplant recipients aged ≥ 18 years * Written informed consent
Exclusion criteria
* Patients undergoing 3rd or subsequent kidney transplant * Patients undergoing a kidney transplantation from DCD Maastricht I, II & IV * Transplant recipients aged \< 18 years * Patients receiving multi-organ transplants * ABO/HLA incompatible transplants * Highly sensitized patients with a panel-reactive antibody (PRA) ≥85% * Kidneys with CIT \> 12 hrs at the point of arrival at transplant centre * Kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder) * Kidneys explanted from a donor on normothermic regional perfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glomerular filtration rate (GFR) | 6 months post transplantation | renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| primary non-function | 6 months post transplantation | defined as permanent lack of graft function from the time of transplantation, was diagnosed when a kidney graft was well perfused (confirmed by ultrasound examination) but never functioned, necessitating dialysis after kidney transplantation |
| delayed graft function (DGF) | 6 months post transplantation | defined as the need for postoperative dialysis during the first 7 days after transplantation |
| glomerular filtration rate (GFR) | 1 month post transplantation | renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation |
| adverse events | 6 months post transplantation | defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the normothermic machine perfusion of the donor kidney prior to transplantation |
| postoperative complications | 6 months post transplantation | graded according to the comprehensive complication index |
| patient and graft survival | 6 months post transplantation | time from transplant to patient death, and graft failure |
Countries
Netherlands
Contacts
Primary ContactAsel Arykbaeva
Backup ContactDorottya K De Vries, MD PhD
Outcome results
None listed