PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration (PROPER)

Leiden University Medical Center (LUMC)

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Procedure: Prolonged normothermic machine perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04693325

NL76344

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Prolonged normothermic machina perfusion

Experimental group

Description:

Eligible and consenting patients who will receive a donor kidney will be included for participation in this study. Current practice is to preserve donor kidneys on hypothermic machine perfusion (HMP). In this study, donor kidneys (n=18) will be taken off the HMP after arrival in the transplant center. These will then be perfused with oxygenated perfusate using the NMP device following an optimised NMP protocol.

Treatment:

Procedure: Prolonged normothermic machine perfusion