Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?

Conditions

Chronic Kidney Failure, Kidney Transplant Failure

Keywords

Normothermic kidney machine perfusion

Brief summary

This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.

Hui Lin, Karim Bousnina, Julia S. Slagter, Yitian Fang, Iacopo Cristoferi et al. (10 authors)

Clinical Transplantation2025-04-252 citations

10.1111/ctr.70163

Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial

Sarah A. Hosgood, Chris Callaghan, Colin Wilson, Laura Smith, Joanne Mullings et al. (10 authors)

Nature Medicine2023-05-25148 citations

10.1038/s41591-023-02376-7

Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial

Elsaline Rijkse, Sarah Bouari, Hendrikus J. A. N. Kimenai, Jeroen de Jonge, Ron W.F. de Bruin et al. (10 authors)

International Journal of Surgery Protocols2021-01-0127 citations

10.29337/ijsp.165

Interventions

PROCEDURENormothermic machine perfusion

Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* kidney-only transplant * renal replacement therapy at time of transplant * receiving standard immunosuppression regimen post-transplant. * Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.

Exclusion criteria

* pre-emptive at time of transplant * receive a multi-organ or dual kidney transplant * age donor or recipient below 18 years * Maastricht type I and II DCD * donor kidneys preserved on static cold storage (SCS) * kidneys retrieved after normothermic regional perfusion (NRP) * Recipient virtual panel reactive antibodies ≥85% * Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with immediate graft function	3 months	Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.

Secondary

Measure	Time frame
Duration of delayed graft function	3 months
estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant	1 year
Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant	1 year
all-cause and death-censored graft survival up to 5 years	5 years
patient survival up to 5 years	5 years

Countries

Netherlands

Outcome results

None listed