Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01149993
Status:
WITHDRAWN
Last Update Posted:
2014-06-09
First Post:
2010-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D051799', 'term': 'Delayed Graft Function'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'FDA clinical hold, IND withdrawn.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-06', 'studyFirstSubmitDate': '2010-06-21', 'studyFirstSubmitQcDate': '2010-06-23', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in ischemia reperfusion injury', 'timeFrame': 'one year', 'description': 'Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury.'}], 'secondaryOutcomes': [{'measure': 'secondary outcomes', 'timeFrame': 'one year', 'description': 'incidence of acute rejection, graft survival, patient survival, change in cylex values'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['living donation', 'kidney transplantation', 'delayed graft function', 'ischemia reperfusion injury'], 'conditions': ['Kidney Transplantation', 'Renal Transplantation', 'Reperfusion Injury']}, 'descriptionModule': {'briefSummary': 'Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Must be able to provide written informed consent.\n2. All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant\n3. All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.\n4. Patients between 18-80 years of age\n\nExclusion Criteria:\n\n1. Recipients of multi-organ transplant\n2. Patients with known allergies of hypersensitivities to any of the drugs used in this protocol\n3. Recipients of kidneys from a deceased donor\n4. Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV\n5. Women who are pregnant\n6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial."}, 'identificationModule': {'nctId': 'NCT01149993', 'briefTitle': 'Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation', 'orgStudyIdInfo': {'id': '2009-496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pre-transplant immunosuppression', 'description': 'subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation.', 'interventionNames': ['Drug: Myfortic (mycophenolic acid)', 'Drug: Thymoglobulin (anti-thymocyte globulin)']}, {'type': 'EXPERIMENTAL', 'label': 'pre-transplant induction', 'description': 'subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.', 'interventionNames': ['Drug: Myfortic (mycophenolic acid)', 'Drug: Thymoglobulin (anti-thymocyte globulin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard of care', 'description': 'subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital', 'interventionNames': ['Drug: Myfortic (mycophenolic acid)', 'Drug: Thymoglobulin (anti-thymocyte globulin)']}], 'interventions': [{'name': 'Myfortic (mycophenolic acid)', 'type': 'DRUG', 'description': '720mg twice a day for 7 days prior to transplantation', 'armGroupLabels': ['pre-transplant immunosuppression']}, {'name': 'Myfortic (mycophenolic acid)', 'type': 'DRUG', 'description': '720mg twice a day after transplant', 'armGroupLabels': ['pre-transplant immunosuppression', 'pre-transplant induction', 'standard of care']}, {'name': 'Thymoglobulin (anti-thymocyte globulin)', 'type': 'DRUG', 'description': 'up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.', 'armGroupLabels': ['pre-transplant immunosuppression', 'pre-transplant induction']}, {'name': 'Thymoglobulin (anti-thymocyte globulin)', 'type': 'DRUG', 'description': 'standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.', 'armGroupLabels': ['pre-transplant immunosuppression', 'pre-transplant induction', 'standard of care']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joseph K Melancon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of kidney and pancreas transplantation', 'investigatorFullName': 'Keith Melancon,MD', 'investigatorAffiliation': 'Georgetown University'}}}}