Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT02055950
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsed Perfusion for Marginal Kidneys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR)', 'timeFrame': '6 months after transplant.'}, {'measure': 'Renal resistance', 'timeFrame': '6 hours after pulsatile machine perfusion', 'description': 'Renal resistance is measured by graft ultrasound. It ranges from 0 to 1.'}], 'secondaryOutcomes': [{'measure': 'Correlation between renal resistance measured at 6 hours after machine perfusion and renal histological score at pre-transplant biopsy', 'timeFrame': '6 hours after pulsatile machine perfusion', 'description': 'The severity of changes in kidney at pre-transplant biopsy was quantified by a predefined histologic score. Changes in each evaluated component of the kidney tissue , vessels, glomeruli, tubules, and connective tissue, received a score ranging from 0 to 3. The sum of these scores was defined as the global kidney score, which could range from 0 to 12.\n\nRenal resistance is measured by graft ultrasound. It ranges from 0 to 1.'}, {'measure': 'Correlation between renal resistances measured at 6 hours after pulsatile machine perfusion and intergraft resistances measured by ultrasound at 7 days and 6 months after transplant.', 'timeFrame': 'Changes from 7 days at 6 months after transplant .', 'description': 'Renal resistances are measured by graft ultrasound. They range from 0 to 1.'}, {'measure': 'Incidence of delayed graft function (DGF).', 'timeFrame': 'Within the first week after transplant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kidney transplant', 'Marginal donors', 'Pulse perfusion', 'Graft function'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Trends in organ donor pool are characterized by an increasing age and a shift towards cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years nowadays represent more than one fourth of the entire donor pool in Italy. This, along with an increasing number of patients on the waiting list for transplantation, prompted a growing use of organs from subjects older than 60 years that would have been considered unsuitable years ago. To improve graft outcomes, transplant of two older kidneys in the same recipient has been proposed. To optimize allocation of these organs to single or dual transplantation,a scoring system for kidneys, based on biopsy, with scores ranging from a minimum of 0 (indicating the absence of renal lesions) to a maximum of 12 (indicating the presence of marked changes in the renal parenchyma) has been suggested. According to this panel, kidneys with a score of 4 or lower are predicted to contain enough viable nephrons to be used as single transplants, those with a score of 5, 6, or 7 can be used as dual transplants, kidneys with a score greater than 7 are discarded. The survival of kidney grafts obtained from donors older than 60 years and allocated for single or dual transplantation on the basis of biopsy findings before transplantation was similar to that of single grafts from younger donors. To further improve these results, set-up of strategies to preserve organs is crucial to save the residual nephron mass and optimize outcomes of these marginal grafts. In this regard, over the past 30 years two methods of kidney preservation have been developed. With cold storage, the kidney is flushed once it is removed from the donor and placed in an ice-cooled container with preservation solution. With the use of pulsatile machine perfusion, the kidney is connected to a machine, which pumps a cold solution containing oxygen and nutrients through the kidney. This process allows for metabolism to continue in the kidney with end products being removed. The broad aim of the present study is to evaluate whether pulsatile machine perfusion of kidneys from older/marginal donors may provide better outcomes than static perfusion. To this purpose the outcome of recipients of perfused kidneys will be compared with the outcome of historical controls receiving non-perfused kidney selected and allocated on the basis of the same criteria and matched by gender, age and kidney histologic score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are eligible to receive a single or dual transplant from older/marginal deceased donors identified according to the Nord Italia Transplant criteria who consent to receive perfused with a pulsatile machine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 50 years or more and no more than 10 years older or younger than their corresponding donors;\n* First single or double kidney transplant from deceased donors older than 60 years;\n* Pre-implantation histologic evaluation and graft selection and allocation based on the histologic score and according to the Nord Italian Transplant (NIT) criteria;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Any factor that according to the NIT selection criteria represent a contraindication to receive a deceased donor kidney transplant\n* Need for specific de-sensitization protocols because of high immunological risk (according to NIT criteria) or participation in other concomitant intervention studies\n* Vascular abnormalities/changes that preclude the possibility to perfuse the kidney grafts by a pulsatile machine'}, 'identificationModule': {'nctId': 'NCT02055950', 'acronym': 'PREDICTION', 'briefTitle': 'Pulsed Perfusion for Marginal Kidneys', 'organization': {'class': 'OTHER', 'fullName': 'Mario Negri Institute for Pharmacological Research'}, 'officialTitle': 'A PROSPECTIVE STUDY TO COMPARE EARLY GRAFT FUNCTION OF RECIPIENTS OF SINGLE OR DUAL KIDNEY ORGANS STORED IN ICE COLD SOLUTION OR PULSED PERFUSION', 'orgStudyIdInfo': {'id': 'PREDICTION'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney perfused by pulsatile machine', 'interventionNames': ['Procedure: Kidney perfused by pulsatile machine']}, {'label': 'Kidney stored in refrigerated solution', 'interventionNames': ['Procedure: Storage of kidney in refrigerated solution']}], 'interventions': [{'name': 'Storage of kidney in refrigerated solution', 'type': 'PROCEDURE', 'armGroupLabels': ['Kidney stored in refrigerated solution']}, {'name': 'Kidney perfused by pulsatile machine', 'type': 'PROCEDURE', 'armGroupLabels': ['Kidney perfused by pulsatile machine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/U.O. Chirurgia Pediatrica', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'IRCCS Policlinico S.Matteo - UOS trapianto di Rene/U.O. Nefrologia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Paolo Cravedi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS - Mario Negri Institute for Pharmacological Research'}, {'name': 'Giuseppe Remuzzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS - istituto di Ricerche Farmacologiche Mario Negri - A.O. Papa Giovanni XXIII BG'}, {'name': 'Giovanni Rota, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia Pediatrica'}, {'name': 'Salvatore De Pascale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia Pediatrica'}, {'name': 'Francesco La Canna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia Pediatrica'}, {'name': 'Giuseppe Piccolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NIT (North Italian Transplant)'}, {'name': 'Giuseppe Rossini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NIT (North Italian Transplant)'}, {'name': 'Sergio Vesconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NIT (North Italian Transplant)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}