Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?
NCT ID: NCT04882254
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2021-05-01
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normothermic machine perfusion
Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate.
Normothermic machine perfusion
Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.
Standard-of-care
Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands.
No interventions assigned to this group
Interventions
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Normothermic machine perfusion
Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Robert Minnee
Transplant surgeon
Locations
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Erasmus MC Transplant Institute
Rotterdam, , Netherlands
Countries
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References
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Lin H, Bousnina K, Slagter JS, Fang Y, Cristoferi I, Garrelds IM, Danser AHJ, Reinders MEJ, Minnee RC, Hoogduijn MJ. (Pro)renin, Erythropoietin, Vitamin D and Urodilatin Release From Human Donor Kidneys During Normothermic Machine Perfusion: Predictors of Early Post-Transplant Outcome? Clin Transplant. 2025 May;39(5):e70163. doi: 10.1111/ctr.70163.
Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
Rijkse E, Bouari S, Kimenai HJAN, de Jonge J, de Bruin RWF, Slagter JS, van den Hoogen MWF, IJzermans JNM, Hoogduijn MJ, Minnee RC. Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial. Int J Surg Protoc. 2021 Oct 6;25(1):227-237. doi: 10.29337/ijsp.165. eCollection 2021.
Other Identifiers
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APOLLO
Identifier Type: -
Identifier Source: org_study_id
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