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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermic machine perfusion | Experimental | Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate. |
|
| Standard-of-care | No Intervention | Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normothermic machine perfusion | Procedure | Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with immediate graft function | Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft. | 3 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC Transplant Institute | Rotterdam | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40278798 | Derived | 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. | |
| 38979743 |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)
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| 1 year |
| all-cause and death-censored graft survival up to 5 years | 5 years |
| patient survival up to 5 years | 5 years |
| 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. |
| 34708171 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |