[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652841":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":97,"studyPopulation":88,"armGroups":98,"interventions":109,"overallOfficials":115,"centralContacts":119,"locations":128,"responsibleParty":174,"collaborators":178,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":188,"sex":194,"minAge":195,"maxAge":88,"enrollmentInfo":196,"targetDuration":88,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":213,"whyStopped":88,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":88},[9],{"measure":10,"description":11,"timeFrame":12},"Renal function after transplantation","Renal function estimated by the glomerular filtration rate at 1 year after transplantation as determined by the Lund Malmö revised formula for eGFR calculated based on creatinine value","One year after transplantation",[14,17,21,24,28,32,35,39,43,47,51,54,57,61,64,67,70,73,76,79,82,85],{"measure":15,"description":16,"timeFrame":12},"1. the iBox score at one year","iBOX scoring system is an innovative composite endpoint that has been validated by EMEA and FDA as the first surrogate end point for clinical studies. iBox is a risk prediction score that utilises multiple clinical and pathological relevant features (estimated glomerular filtration rate (eGFR), proteinuria, anti-human leukocyte antigen donor-specific antibody, and kidney graft biopsy histopathology) at one-year post-transplant to predict the likelihood of the transplanted kidney to fail over fixed intervals (3, 5, and 7 years). The output is presented as a continuous mathematical percentage and the score is interpreted as the absolute statistical risk of losing the kidney graft.",{"measure":18,"description":19,"timeFrame":20},"Graft (uncensored and censored for recipient death) survival","Survival rate of kidney transplant","One year after transplant",{"measure":22,"description":23,"timeFrame":12},"Patient survival","Proportion of patient survivint",{"measure":25,"description":26,"timeFrame":27},"Delayed graft function","Need for dialysis for all causes within the first 7 days after kidney transplantation.","7 days after transplantation",{"measure":29,"description":30,"timeFrame":31},"Postoperative complications","Post operative complications measured by the comprehensive complication index (CCI). CCI ranges from 0 to 100, with higher scores reflecting higher number and more severe complications","Three months and one year after transplant",{"measure":33,"description":34,"timeFrame":12},"Incidence of acute rejection","The proportion of patients having biopsy proven acute rejection episodes",{"measure":36,"description":37,"timeFrame":38},"Health economic analysis","Health economic analysis and cost effectiveness analysis of using ex situ oxygenated machine perfusion in addition to NRP in DCD kidney transplantation","One year post transplantation",{"measure":40,"description":41,"timeFrame":42},"Kidney Disease Quality of Life (KDQOL)","Recipient health related quality of life post transplantation measured specifically for individuals with chronic kidney disease. Range 0-100 with higher values reflecting better quality of life.","Three months and one year after transplantation",{"measure":44,"description":45,"timeFrame":46},"Kidney transplant questionnaire KTQ-25","Evaluates the health related quality of life specifically in patients who have undergone a kidney transplant on a 7 point Likert scale with lower score reflecting a worse state.","Three months and one year post transplant",{"measure":48,"description":49,"timeFrame":50},"EQ-5D-5L","A measure of generic health related quality of life and health status with three dimensions:\n\n* health state profile (range from 11111 -perfect health to 55555 worst health)\n* utility score (with a score of 1 representing perfect health and a score of 0 representing a health state equivalent to death)\n* visual analogue score ranging from 0 -worst health to 100 - best health","Three months and one year post transplant.",{"measure":52,"description":53,"timeFrame":46},"36-Item Short Form Health Survey (SF-36)","Patient reported health-related quality of life measured on a 0-100 scale where 100 represents the best status and 0 the worst status.",{"measure":55,"description":56,"timeFrame":38},"Biomarkers of kidney injury","We will also measure various biomarkers of kidney injury and inflammation in perfusate, tissue, and blood samples, including lactate dehydrogenase, D-dimer, cardiolipin, Neutrophil Gelatinase-Associated Lipocalin, Kidney Injury Molecule-1, Glutathione S-transferase, interleukin-18, fatty acid binding protein, and microRNA 21 and proteomic analyses.",{"measure":58,"description":59,"timeFrame":60},"Donor derived cell free DNA","Quantification of kidney injury post transplant measured as absolute quantification and fractional abundance","6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation",{"measure":62,"description":63,"timeFrame":60},"D-dimers","Measures the risk of microthrombosis in the kidney transplant with higher levels indicating micro thrombosis of the kidney.",{"measure":65,"description":66,"timeFrame":60},"Neutrophil Gelatinase-Associated Lipocalin (NGAL)","Measures the level of acute kidney injury with higher level denoting more sever injuries.",{"measure":68,"description":69,"timeFrame":60},"cardiolipin antibodies","Measures the risk of vascular complications and early graft failure with higher level denoting increased risk of transplant failure.",{"measure":71,"description":72,"timeFrame":60},"Kidney Injury Molecule-1 (KIM-1)","Non invasive biomarker of early proximal tubular injury with level and risk of DGF and acute rejection",{"measure":74,"description":75,"timeFrame":60},"Glutathione S-Transferase (GST)","Biomaker of kidney injury measuring the level of cellular damage in the kidney transplant with higher levels suggesting a greater degree of damage",{"measure":77,"description":78,"timeFrame":60},"Interleukin-18 (IL-18)","Biomarker measured in the urine to identify acute ischemic and inflammatory injuries with higher levels indicating greater damage.",{"measure":80,"description":81,"timeFrame":60},"Liver-type Fatty Acid-Binding Protein (L-FABP)","Non-invasive urine biomarker used to detect allograft ischemia and oxidative stress",{"measure":83,"description":84,"timeFrame":60},"microRNA-21 (miR-21)","Non-invasive genetic biomarker to predict delayed graft function and monitor the progression of chronic tissue scarring.",{"measure":86,"description":87,"timeFrame":60},"Urinary proteome analysis","Cutting-edge diagnostic tool in kidney transplantation \\[1\\]. Instead of tracking a single protein, it measures patterns of hundreds of distinct protein fragments simultaneously to detect early allograft rejection and predict long-term organ survival.",null,{"allocation":90,"interventionModel":91,"interventionModelDescription":88,"primaryPurpose":92,"observationalModel":88,"timePerspective":88,"maskingInfo":93},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":94,"maskingDescription":88,"whoMasked":95},"SINGLE",[96],"PARTICIPANT","The trial is designed as a randomised, controlled, multicentre superiority trial with the primary endpoint of eGFR at one year after kidney transplant. The trial will be carried out in the four academic hospitals with renal transplant programs in Sweden: Stockholm, Gothenburg, Malmo and Uppsala. Randomisation 1:1 and eCRF will be done using RedCap.\n\nEach eligible kidney for the trial will be randomised 1:1 between the following groups:\n\nGroup 1 - control group: Following in-situ NRP and in-situ flushing, the kidney will be packed in a storage box and stored on ice until back-table preparation before transplantation at the recipient centre.\n\nGroup 2 - intervention group: Following in-situ NRP and in-situ flushing, the kidney will be placed on the Kidney Assist Transporter HMPO2 device and perfused with oxygenated Belzers Machine Preservation Solution at a pulsatile pressure of 25 mmHg starting immediately after retrieval until back-table preparation before kidney transplantation at the transplant centre. Oxygen will be delivered at a rate of 100 ml\u002Fmin via an oxygenator from a portable oxygen cylinder, resulting in a partial oxygen tension in the perfusate of 90 kPa (for reference, +\u002F- 675 mmHg).\n\nKidney donors All standard allocation rules and recipient matching will be undertaken according to standard practice. Randomisation 1:1 of the kidneys between the two study arms will be done once the recovery of the organs is completed successfully with NRP and both kidneys are accepted for transplant. One kidney will be allocated to static cold storage preservation arm and the other to HMPO2 arm. If both kidneys are transplanted at the same centre, an additional stratification will determine which kidney will be transplanted first. If only one kidney is recovered or allocated to a Swedish centre, this will be randomised following a kidney alone randomisation procedure. Kidneys will be shared between the four transplant centres according to clinical protocols in place. The care of the donor and the NRP recovery procedure, will be performed according to standard practice.\n\nKidney recipients Written consent regarding trial participation will be sought from all patients on the waiting list or for the newly listed patients, at the time of listing. Kidney recipients will be selected according to national organ allocation rules, independent of participation in the trial. Surgery will be performed according to local clinical protocols and postoperative care managed according to standard of care. During the follow-up, biopsies will be performed according to the local standard of care and if indicated for clinical management. At the end of the one year follow up, a renal biopsy will be taken to determine the iBox score. The clinical care of the patients will reflect the current standard of care at the recipient hospital with no deviation from routine care protocols.\n\nModifications\n\n* Since the intervention is a one-time event occurring prior to transplantation, the assigned study intervention will not need to be modified or discontinued once the kidney is transplanted.\n* If the machine fails, the kidney will be end up being cold stored on the device. If these kidneys are transplanted, the recipient will still be included in the secondary modified intention-to-treat analysis according to the treatment actually received.\n\nAdherence Since the intervention occurs prior to the transplantation procedure, there are no measures to assure adherence to study intervention. For data collection, all variables beside the 1-year study biopsy are part of standard of care after kidney transplantation so no additional measures are needed. As one year biopsy is not part of routine care in all centres, all study participants will be consented for the biopsy and will have the option to opt out. A subgroup analysis will be undertaken in those patients for whom a one year biopsy is undertaken. All study participants that consented to participation, will receive a written invitation for the biopsy performed at the local centre.\n\nFollow up visits All follow-up visits and endpoint measures besides the 1-year biopsy are standard of care after renal transplantation in Sweden. The patient will receive an invitation for the 1-year biopsy if they've signed the informed consent for biopsy. Data will be collected from patient medical records after informed consent. Data will be accessed in medical records.\n\nDuring the trial the following data will be retrieved:\n\n* Donor demographics\n* Recipient demographics\n* NRP and Preservation parameters\n* Surgical and clinical variables\n* Graft and patient survival\n* Follow-up data (including complications, adverse events, biopsy and biochemical markers)\n\nVariables and data collection Data will be collected on RedCap for the trial. All blood sampling will be undertaken as part of the routine clinical follow-up with additional study specific samples as above.\n\nRecruitment Approximately 100 kidney transplants from DCD donors are performed each year in Sweden. Although these numbers are expected to increase by about 20%-30% over the next 3 years, researchers planned recruitment on the current level of activity and are confident that 107 eligible kidney pair recipients will be recruited in 36 months (allowing for a the drop out in follow-up and for organs allocated in Scandiatransplant in the STAMP exchange and the payback system between countries). The researchers therefore estimate an enrolment of about 214 DCD kidney transplants during the study period.\n\nStudy duration The study is planned to start in January 2027 and with patient inclusion between March 2027 and December 2029, with a one year follow until December 2030. Written summary and presentation of findings in peer-reviewed journals is planned to be completed by March 2031.",[99,105],{"label":100,"type":101,"description":102,"interventionNames":103},"NRP + HMPO2","EXPERIMENTAL","DCD kidneys recovered with NRP and undergoing ex situ HMPO2 initiated at donor hospital as the intervention",[104],"Device: Ex situ hypothermic oxygenated machine preservation",{"label":106,"type":107,"description":108,"interventionNames":88},"NRP alone","NO_INTERVENTION","DCD kidneys recovered with NRP followed by static cold storage",[110],{"type":111,"name":112,"description":113,"armGroupLabels":114,"otherNames":88},"DEVICE","Ex situ hypothermic oxygenated machine preservation","Ex situ preservation of NRP DCD kidneys with hypothermic oxygenated machine perfusion",[100],[116],{"name":117,"affiliation":5,"role":118},"Gabriel C Oniscu, MD, PhD, FRCS","STUDY_CHAIR",[120,124],{"name":117,"role":121,"phone":122,"phoneExt":88,"email":123},"CONTACT","+46-702768684","gabriel.oniscu@regionstockholm.se",{"name":125,"role":121,"phone":126,"phoneExt":88,"email":127},"Alexandra Thorsell","+46760217086","alexandra.thorsell@regionstockholm.se",[129,148,161],{"facility":130,"status":88,"city":131,"state":88,"zip":88,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":139,"contacts":140},"Sahlgrenska University Hospital","Gothenburg","Sweden","SE",{"type":135,"coordinates":136},"Point",[137,138],11.96679,57.70716,{"lat":138,"lon":137},[141,145],{"name":142,"role":121,"phone":143,"phoneExt":88,"email":144},"Åsa Noren, MD, PhD","+46702901819","asa.m.noren@vgregion.se",{"name":146,"role":121,"phone":147,"phoneExt":88,"email":144},"Mihai Oltean, MD, PhD","+46704906156",{"facility":149,"status":88,"city":150,"state":88,"zip":88,"country":132,"countryCode":133,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Skåne University Hospital","Malmö",{"type":135,"coordinates":152},[153,154],13.00073,55.60587,{"lat":154,"lon":153},[157],{"name":158,"role":121,"phone":159,"phoneExt":88,"email":160},"Alireza Biglarnia, MD, PhD","+46702377818","alireza.biglarnia@med.lu.se",{"facility":162,"status":88,"city":163,"state":88,"zip":88,"country":132,"countryCode":133,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Akademiska Hospital","Uppsala",{"type":135,"coordinates":165},[166,167],17.63889,59.85882,{"lat":167,"lon":166},[170],{"name":171,"role":121,"phone":172,"phoneExt":88,"email":173},"Amir Sedigh, MD, PhD","+46708750525","amir.sedigh@akademiska.se",{"type":175,"investigatorFullName":176,"investigatorTitle":177,"investigatorAffiliation":5,"oldNameTitle":88,"oldOrganization":88},"PRINCIPAL_INVESTIGATOR","Gabriel Oniscu MD, PhD, FRCS","Professor of Transplantation Surgery",[179,181,183,184],{"name":180,"class":6},"Uppsala University Hospital",{"name":182,"class":6},"Skane University Hospital",{"name":130,"class":6},{"name":185,"class":6},"Karolinska University","100652841","nrp--ex-situ-hmpo2-vs-nrp-alone-in-dcd-kidney-transplantation-100652841",false,"NCT07779187","NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation","Oxygenated Perfusion for Enhanced Renal Function in Donation After Circulatory Death (DCD) Kidney Transplants (OxyPERF) - A National Swedish Randomized Controlled Trial","OxyPerf","Inclusion Criteria:\n\nDonor kidneys:\n\n1. All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.\n2. Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)\n\nRecipients:\n\n1. All adult patients (\\>18 yrs old) eligible for renal transplantation during study duration.\n2. Recipient consented for surgery, matched to a DCD kidney.\n\nExclusion Criteria:\n\nDonor kidneys:\n\n1\\. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules.\n\nRecipients:\n\n1. Paediatric patients (\\\u003C18 yrs old).\n2. Participation in other clinical drug or medical devices trials.\n3. Patient subject to combined transplant of kidney + other organ.","ALL","18 Years",{"count":197,"type":198},214,"ESTIMATED","INTERVENTIONAL",[201],"NA","The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:\n\n* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone.\n* Are the postoperative complications and outcomes different between the two groups?\n* Is the quality of life of recipients different between the two groups?\n* Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.\n\nParticipants will:\n\n* Receive a kidney treated with one of the two strategies.\n* Visit the clinic as per usual clinical practice for checkups and tests\n* Report on their quality of life pre and post transplant\n* Undergo a kidney biopsy at one year to forecast long term transplant function",[204,205],"Kidney Transplant","DCD Kidney",[207,208,209,210,211,212,36],"DCD kidneys","Normothermic Regional Perfusion (NRP)","Hypothermic oxygenated perfusion","Patient reported outcomes","Kidney transplants","Randomised Control Trial","NOT_YET_RECRUITING","2026-08-20",{"date":216,"type":217},"2026-08-21","ACTUAL",{"date":219,"type":198},"2027-01-01",{"date":221,"type":198},"2030-12-31",{"name":5,"class":6},3]