NCT04693325

PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
PROCEDURE	Prolonged 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) \[PNMP6\].

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-07-01
• Completion: 2023-01-01
• First posted: 2021-01-05
• Last updated: 2022-01-03

Locations

2 sites across 1 country: Netherlands