Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT02671318
Status:
UNKNOWN
Last Update Posted:
2016-08-17
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D001379', 'term': 'Azathioprine'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytomegalovirus infection/disease recurrence', 'timeFrame': 'One year', 'description': 'Cytomegalovirus infection/disease recurrence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cytomegalovirus', 'sirolimus', 'cytomegalovirus recurrence', 'kidney transplant', 'conversion'], 'conditions': ['Cytomegalovirus Infections']}, 'referencesModule': {'references': [{'pmid': '37046380', 'type': 'DERIVED', 'citation': 'Viana LA, Cristelli MP, Basso G, Santos DW, Dantas MTC, Dreige YC, Requiao Moura LR, Nakamura MR, Medina-Pestana J, Tedesco-Silva H. Conversion to mTOR Inhibitor to Reduce the Incidence of Cytomegalovirus Recurrence in Kidney Transplant Recipients Receiving Preemptive Treatment: A Prospective, Randomized Trial. Transplantation. 2023 Aug 1;107(8):1835-1845. doi: 10.1097/TP.0000000000004559. Epub 2023 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence.\n\nNamely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence.\n\nGiven this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.', 'detailedDescription': 'This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult kidney transplant recipients \\> 18 y.o.\n* Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.\n\nExclusion Criteria:\n\n* Re-transplant;\n* Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;\n* Acute rejection episode in the last 30 days, or episode \\> 2A in the Banff criteria;\n* GFR (MDRD) \\< 40 ml/min;\n* Proteinuria \\> 0,5 g/l;\n* Hemoglobin \\< 10 g/l and/or leucocytes \\< 4000 cels/mm3 and/or platelets \\< 150.000 cels/mm3;\n* Triglycerides \\> 500 mg/dl with or without use of fibrate;\n* Cholesterol total \\> 300 mg/dl with or without use of statin;\n* Hepatic abnormalities;\n* Significant periphery edema;\n* Pulmonary abnormalities or breast x-ray abnormalities;\n* Hyper sensibility to sirolimus formula;'}, 'identificationModule': {'nctId': 'NCT02671318', 'acronym': 'StopCMV', 'briefTitle': 'Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Rim e Hipertensão'}, 'officialTitle': 'Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)', 'orgStudyIdInfo': {'id': '43102815.0.0000.5505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug conversion to sirolimus', 'description': 'Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.', 'interventionNames': ['Drug: Drug conversion to sirolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maintenance of the current regimen', 'description': 'Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.', 'interventionNames': ['Drug: Maintenance of the current regimen']}], 'interventions': [{'name': 'Drug conversion to sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.', 'armGroupLabels': ['Drug conversion to sirolimus']}, {'name': 'Maintenance of the current regimen', 'type': 'DRUG', 'otherNames': ['Myfortic', 'Immuran'], 'description': 'Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.', 'armGroupLabels': ['Maintenance of the current regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04037-003', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Geovana Basso, MD', 'role': 'CONTACT', 'email': 'geovana_basso@hotmail.com', 'phone': '+55 11 5087-8000'}], 'facility': 'Hospital do Rim', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Geovana Basso, MD', 'role': 'CONTACT', 'email': 'geovana_basso@hotmail.com', 'phone': '+55 11 50878000'}], 'overallOfficials': [{'name': 'Geovana Basso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}, {'name': 'Helio Tedesco Silva Junior, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}, {'name': 'Claudia Rosso felipe, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}, {'name': 'Leonardo V. Riella, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Brigham and Women's Hospital, US."}, {'name': 'Jose O. Medina Pestana, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Rim e Hipertensão', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Geovana Basso', 'investigatorAffiliation': 'Hospital do Rim e Hipertensão'}}}}