Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT03749356
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-03', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)', 'timeFrame': 'until 24 weeks', 'description': 'The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)'}], 'secondaryOutcomes': [{'measure': 'Incidence of biopsy-confirmed acute rejection(TCMR, AMR)', 'timeFrame': 'until 24 weeks', 'description': 'The frequency and Incidence'}, {'measure': 'Pathological results of acute rejection', 'timeFrame': 'until 24 weeks', 'description': 'By Banff classification categories'}, {'measure': 'Survival rate of transplated organ', 'timeFrame': 'at 24 weeks', 'description': 'Kaplan-Meier'}, {'measure': 'Survival rate of Patients', 'timeFrame': 'at 24 weeks', 'description': 'Kaplan-Meier'}, {'measure': 'Serum-Cr, eGFR', 'timeFrame': 'at 24 weeks', 'description': 'eGFR using CKD-epi method'}, {'measure': 'Evaluate safety of TacroBell SR. cap. from number of participants with adverse events', 'timeFrame': 'until 24 weeks', 'description': 'safety data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.', 'detailedDescription': 'This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 20 years old(male or female)\n* Patients who are planning to receive a kidney from a deceased or a living non-related/related donor\n* Agreement with written informed consent\n\nExclusion Criteria:\n\n* Previously received organs other than kidneys or who are planed to be transplanted simultaneously\n* Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient\n* Receive a kidney from a related donor who showed HLA-0 mismatch (identical)\n* Undergo desensitization therapy with high sensitization\n* Diagnosed with cancer in the last five years \\[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.\\]\n* Patients or donors who have positive HIV test result\n* Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders\n* Severe systemic infection requiring treatment\n* Prior to the kidney transplantation\n\n * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit\n * WBC\\< 2,500/mm\\^3, or platelet \\< 75,000/mm\\^3, or ANC \\< 1,300/mm\\^3\n* Pregnant women or nursing mothers\n* Fertile women who not practice contraception with appropriate methods\n* Participated in other trial within 4 weeks\n* In investigator's judgment"}, 'identificationModule': {'nctId': 'NCT03749356', 'acronym': 'OPIRUS', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': '211KT18008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Once-Daily Tacrolimus', 'description': 'One arm: TacroBell SR Cap.', 'interventionNames': ['Drug: TacroBell SR cap.']}], 'interventions': [{'name': 'TacroBell SR cap.', 'type': 'DRUG', 'otherNames': ['Tacrolimus SR cap.'], 'description': '* Orally, once-daily in the morning\n* After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\\~12ng/ml for 0 to 3months and then at 3\\~8ng/ml for 3 to 6months of study treatment.', 'armGroupLabels': ['Once-Daily Tacrolimus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yu Seun Kim, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}