Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-26 @ 5:00 PM
Study NCT ID:
NCT04906304
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Safety and Efficacy of de Novo Everolimus
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': 'D000068338', 'term': 'Everolimus'}, {'id': 'C014635', 'term': 'lactitol'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'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': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-27', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMV Infection', 'timeFrame': '6 months', 'description': 'CMV PCR quantitative count'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cytomegalovirus Infections']}, 'descriptionModule': {'briefSummary': 'Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.', 'detailedDescription': 'This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Transplanted patients \\> 18 years\n\nExclusion Criteria:\n\n* Simultanous Kidney -Pancreas Transplantation'}, 'identificationModule': {'nctId': 'NCT04906304', 'briefTitle': 'Comparison of Safety and Efficacy of de Novo Everolimus', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Comparison of Safety and Efficacy of de Novo Everolimus Plus Low Dose of Cyclosporine With Standard Dose of Cyclosporine Plus Cellcept on CMV and BK Virus Infections Prevention in Renal Transplant Patients', 'orgStudyIdInfo': {'id': 'UNRC940401/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evrolimus', 'description': 'The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose pluse cellcept', 'interventionNames': ['Drug: Everolimus Pill', 'Drug: Sandimmun (Neoral) dose plus cellcept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': '0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept', 'interventionNames': ['Drug: Everolimus Pill', 'Drug: Sandimmun (Neoral) dose plus cellcept']}], 'interventions': [{'name': 'Everolimus Pill', 'type': 'DRUG', 'otherNames': ['Novartis'], 'description': 'standard dose versus low dose Sandimun', 'armGroupLabels': ['Control', 'Evrolimus']}, {'name': 'Sandimmun (Neoral) dose plus cellcept', 'type': 'DRUG', 'description': 'Sandimmun (Neoral) dose plus cellcept', 'armGroupLabels': ['Control', 'Evrolimus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Nooshin Dalili', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'SBMU University of Medical Sciences', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant Professor of SBMU', 'investigatorFullName': 'nooshin dalili', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}