Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-02-02 @ 10:15 AM
Study NCT ID:
NCT00656695
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2008-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523752', 'term': 'Iminoral'}, {'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2008-04-07', 'studyFirstSubmitQcDate': '2008-04-07', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transplanted kidney acute rejection', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'cyclosporine side effects', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Iminoral', 'Neoral', 'Acute renal transplant rejection'], 'conditions': ['End Stage Renal Disease', 'Renal Transplantation']}, 'referencesModule': {'references': [{'pmid': '26086833', 'type': 'DERIVED', 'citation': 'Khatami SM, Taheri S, Azmandian J, Sagheb MM, Nazemian F, Razeghi E, Shahidi S, Sadri F, Shamshiri AR, Sayyah M. One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients. Exp Clin Transplant. 2015 Jun;13(3):233-8.'}]}, 'descriptionModule': {'briefSummary': 'Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. renal transplantation candidates\n2. written consent\n3. not taking participate in any other clinical trial in last 3 months\n\nExclusion Criteria:\n\n1. primary FSGS\n2. hyperoxaluria\n3. age under 18\n4. multi organ transplantation\n5. any malignancy in 5 years\n6. PRA \\> 25%\n7. use of Tacrolimus\n8. hyper acute rejection'}, 'identificationModule': {'nctId': 'NCT00656695', 'briefTitle': 'Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Imam Khomeini Hospital'}, 'officialTitle': 'The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients', 'orgStudyIdInfo': {'id': 'iminoral'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'taking Iminoral', 'interventionNames': ['Drug: Iminoral']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'taking Neoral', 'interventionNames': ['Drug: Neoral']}], 'interventions': [{'name': 'Iminoral', 'type': 'DRUG', 'description': 'Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily', 'armGroupLabels': ['1']}, {'name': 'Neoral', 'type': 'DRUG', 'description': 'Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Imam Khomeini Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohammad R Khatami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imam Khomeini Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Khomeini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohammad Reza Khatami', 'investigatorAffiliation': 'Imam Khomeini Hospital'}}}}