Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?
NCT04882254 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-05-07
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.
Conditions
- Kidney Transplant Failure
- Chronic Kidney Failure
Interventions
- PROCEDURE
-
Normothermic machine perfusion
Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-01
- Primary Completion
- 2024-05-06
- Completion
- 2025-05-31
Countries
- Netherlands
Study Locations
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