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Not Yet Recruiting
NCT05703633
Transplantation of Uncontrolled DCD Kidneys REconditioned by a Novel Ex-VIVo Perfusion MEthod
Conditions: End-Stage Kidney Disease
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE1, PHASE2
Enrollment: 8
Sponsor: Sahlgrenska University Hospital, Sweden
Summary
Eight patient will be transplanted with kidneys from donors dying after uncontrolled circulatory arrest (uDCD), with prolonged warm ischemia (up to 4,5 hours), preserved by a new method based on removal of fibrinogen/fibrin in the capillary systems, leading to an effective oxygenation of the tissue using an ex-vivo hospital manufactured perfusion device, minimizing the risk for ischemia-reperfusion injury (I/R-I) after kidney transplantation.Each patient will be studied for three months, with long-term follow-up data collected at 6 and 12 months
Eligibility Criteria
Inclusion Criteria:Both sexesAge 18 - 65First-time transplantABO blood-group identicalLiving within 4 hours from transplant siteWritten consentExclusion Criteria:Human Leukocyte Antigen (HLA) antibodies and/or preformed donor specific antibodies (DSA)Total ischemia time of > 16 hoursMulti organ transplant recipients or previously transplantedABO-incompatible or positive complement-dependent crossmatch (CDC X-match)Contraindicating medical conditionContraindicating malignancyRecent drug abuseNon-adherent or difficulties understanding the protocolKnown risk factors for technical surgical complications (i.e.
serious arteriosclerosis and or obesity)
Source: ClinicalTrials.gov (NCT05703633). StuddyBuddy aggregates publicly available trial information.