Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-08 @ 8:28 PM
Study NCT ID:
NCT01014234
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2009-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapamycin and Regulatory T Cells in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2009-11-13', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The absolute number of T-reg after renal transplant in patients in treatment with rapamycin compared to patients treated with cyclosporine', 'timeFrame': 'Every 6 months after the transplantation'}], 'secondaryOutcomes': [{'measure': 'Adverse events developed during the duration of the clinical study, that damage the patient, that is not part of the natural history of the disease.', 'timeFrame': 'Every two months during the follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunosuppressive Agents', 'Immune system regulation', 'Regulatory T cells', 'Rapamycin', 'Tolerance'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '17142730', 'type': 'BACKGROUND', 'citation': 'Battaglia M, Stabilini A, Migliavacca B, Horejs-Hoeck J, Kaupper T, Roncarolo MG. Rapamycin promotes expansion of functional CD4+CD25+FOXP3+ regulatory T cells of both healthy subjects and type 1 diabetic patients. J Immunol. 2006 Dec 15;177(12):8338-47. doi: 10.4049/jimmunol.177.12.8338.'}, {'pmid': '19744094', 'type': 'BACKGROUND', 'citation': 'San Segundo D, Fernandez-Fresnedo G, Ruiz JC, Rodrigo E, Benito MJ, Arias M, Lopez-Hoyos M. Two-year follow-up of a prospective study of circulating regulatory T cells in renal transplant patients. Clin Transplant. 2010 May-Jun;24(3):386-93. doi: 10.1111/j.1399-0012.2009.01086.x. Epub 2009 Sep 11.'}, {'pmid': '19715919', 'type': 'BACKGROUND', 'citation': 'Ramirez E, Morales JM, Lora D, Mellado M, Cevey M, Alfaro FJ, De Pablos P, Andres A, Paz-Artal E, Serrano A. Peripheral blood regulatory T cells in long-term kidney transplant recipients. Transplant Proc. 2009 Jul-Aug;41(6):2360-2. doi: 10.1016/j.transproceed.2009.05.007.'}]}, 'descriptionModule': {'briefSummary': 'The immune system response is mediated by the interaction between the antigen presenting cell (APC), CD4+ T helper cells (Th) and CD4+ CD25+ regulatory T cells, a subgroup of CD4+ T cell which express IL-2 receptor (CD25) and the transcriptional factor foxp3. Regulatory T cell may contribute to the maintenance of tolerance by suppressing the immune response to normal or tumor associated antigens.\n\nRegulatory T cell emerge from the thymus during ontogenesis and they represent about 10 % of the peripheral Cd4+ t cells.\n\nRapamycin is one the most use treatment to prevent renal allograft failure. Differently from calcineurin inhibitors (cyclosporine and tacrolimus), that inhibit T-cell activation through the inhibition of calcineurin activation, rapamycin inhibits cellular proliferation by impairing the progression of the cellular cycle, in particular by interaction with mTOR. Recently Battaglia et al. have demonstrated a Treg amplification in murine CD4+ lymphocytes treated with rapamycin in vitro.\n\nAim of the study is to evaluate the effect of different immunosuppressive regimens on regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney transplanted patients, more than cyclosporine treatment.', 'detailedDescription': 'It is two years randomised controlled trial in parallel groups.\n\nIt has been resolved to compare different immunosuppressive regimens:\n\n1. cyclosporine+ mycophenolate+prednisone\n2. rapamycin + mycophenolate + prednisone, this treatment should be introduced after one month from renal transplantation.\n\nPatient should visited at month 1-6-12-24 from the transplant. During the control we will reported the following data: physical examination, blood test (blood count, creatinin, BUN, immunosuppressive blood concentration, histological response of surveillance renal biopsy), blood pressure, attendant change of current therapy, pathological variation, or any hospitalisation both ordinary or in DH regimen.\n\nMoreover in all control visit it will be collected a blood sample for evaluation of regulatory t cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female aged from 18 to 75 years\n* Transplanted patients from cadaveric donors\n* Patients who has given written informed consensus\n\nExclusion Criteria:\n\n* Legally unable patients\n* Patients who have been participated to others studies in the last 3 months\n* Addicted to alcohol or smoking'}, 'identificationModule': {'nctId': 'NCT01014234', 'briefTitle': 'Rapamycin and Regulatory T Cells in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Rapamycin and Regulatory T Cells in Renal Transplant Patients: a Two-year Randomized Prospective Study', 'orgStudyIdInfo': {'id': '20070034809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycin', 'description': 'Maintenance treatment with rapamycin + mycophenolate + prednisone. This treatment will be introduced one month after renal transplantation.', 'interventionNames': ['Drug: Rapamycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cyclosporine', 'description': 'Maintenance treatment with cyclosporine + mycophenolate + prednisone. This treatment will be introduced one month after renal transplantation.', 'interventionNames': ['Drug: Cyclosporins']}], 'interventions': [{'name': 'Cyclosporins', 'type': 'DRUG', 'otherNames': ['Neoral'], 'description': 'These patients will undergo maintenance immunosuppressive treatment with cyclosporine + mycophenolate + prednisone according to established clinical practice. The dosage of drugs will be based on evaluations of serum trough levels and it will be adjusted when necessary.', 'armGroupLabels': ['cyclosporine']}, {'name': 'Rapamycin', 'type': 'DRUG', 'otherNames': ['Sirolimus', 'Rapamune'], 'description': 'These patients will undergo maintenance immunosuppressive treatment with rapamycin + mycophenolate + prednisone according to established clinical practice. The dosage of drugs will be based on evaluations of serum trough levels and it will be adjusted when necessary.', 'armGroupLabels': ['Rapamycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Policlinico Fondazione IRCCS "San Matteo"', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Antonio Dal Canton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Fondazione IRCCS "San Matteo", Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Carmelo Libetta', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}