Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT05086003
Status:
RECRUITING
Last Update Posted:
2021-10-28
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016026', 'term': 'Bone Marrow Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Combined kidney and bone marrow transplantation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.', 'timeFrame': '12 months', 'description': 'Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal transplantation', 'Bone marrow transplantation', 'Immune tolerance', 'Immunosuppression'], 'conditions': ['Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18 years\n* Matched siblings\n* No contra-indication to thymoglobuline or total lymphoid irradiation\n\nExclusion Criteria:\n\n* Pregnant women or breast feeding\n* Infection with HIV, HBV or HCV\n* Previous or presnt malignancy'}, 'identificationModule': {'nctId': 'NCT05086003', 'briefTitle': 'Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs', 'orgStudyIdInfo': {'id': '0759-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kidney and bone marrow transplantation', 'description': 'Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation', 'interventionNames': ['Combination Product: Combined kidney and bone marrow transplantation']}], 'interventions': [{'name': 'Combined kidney and bone marrow transplantation', 'type': 'COMBINATION_PRODUCT', 'description': 'Combined kidney and bone marrow transplantation', 'armGroupLabels': ['Kidney and bone marrow transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Moshe Yeshurun', 'role': 'CONTACT', 'email': 'moshe.yeshurun@gmail.com', 'phone': '0526015543'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Moshe Yeshurun, MD', 'role': 'CONTACT', 'email': 'moshe.yeshurun@gmail.com', 'phone': '0526015543'}, {'name': 'Liat Shargian, MD', 'role': 'CONTACT', 'email': 'liatshr@clalit.org.il', 'phone': '0542394930'}], 'overallOfficials': [{'name': 'Moshe Yeshurun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institution of Hematology, Rabin Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Moshe Yeshurun, Head Bone Marrow Unit', 'investigatorFullName': 'moshe yeshurun', 'investigatorAffiliation': 'Rabin Medical Center'}}}}