Clinical trial NCT04693325: PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration
Official title: PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: normothermic machine perfusion
renal transplantation
kidney transplantation
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: glomerular filtration rate (GFR)
timeFrame: 6 months post transplantation
Secondary outcomes:
measure: glomerular filtration rate (GFR)
timeFrame: 1 month post transplantation
measure: glomerular filtration rate (GFR)
timeFrame: 3 months post transplantation
measure: primary non-function
timeFrame: 6 months post transplantation
measure: delayed graft function (DGF)
timeFrame: 6 months post transplantation
measure: patient and graft survival
timeFrame: 6 months post transplantation
measure: adverse events
timeFrame: 6 months post transplantation
measure: postoperative complications
timeFrame: 6 months post transplantation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Ian PJ Alwayn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: