Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT00987103
Status:
UNKNOWN
Last Update Posted:
2010-10-22
First Post:
2009-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2009-09-29', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve, bioavailability, time of maximal concentration, elimination constant', 'timeFrame': 't = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal transplantation', 'tacrolimus', 'pharmacokinetics', 'rectal', 'sublingual', 'rectal administration', 'sublingual administration'], 'conditions': ['Organ Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included.\n* Age: 18 - 65 years\n* Patient's informed consent\n\nExclusion Criteria:\n\n* Patients that use drugs that interact with tacrolimus\n* Patients that participate in other studies\n* Patients that are treated with tacrolimus"}, 'identificationModule': {'nctId': 'NCT00987103', 'briefTitle': 'Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients', 'orgStudyIdInfo': {'id': '09-2-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sublingual - Rectal - Oral', 'description': 'Administration order of rank: Sublingual - Rectal - Oral', 'interventionNames': ['Drug: Tacrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Sublingual - Oral - Rectal', 'description': 'Administration order of rank: Sublingual - Oral - Rectal', 'interventionNames': ['Drug: Tacrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Oral - Sublingual - Rectal', 'description': 'Administration order of rank: Oral - Sublingual - Rectal', 'interventionNames': ['Drug: Tacrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Oral - Rectal - Sublingual', 'description': 'Administration order of rank: Oral - Rectal - Sublingual', 'interventionNames': ['Drug: Tacrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Rectal - Sublingual - Oral', 'description': 'Administration order of rank: Rectal - Sublingual - Oral', 'interventionNames': ['Drug: Tacrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Rectal - Oral - Sublingual', 'description': 'Administration order of rank: Rectal - Oral - Sublingual', 'interventionNames': ['Drug: Tacrolimus']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograft'], 'description': 'Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg', 'armGroupLabels': ['Oral - Rectal - Sublingual', 'Oral - Sublingual - Rectal', 'Rectal - Oral - Sublingual', 'Rectal - Sublingual - Oral', 'Sublingual - Oral - Rectal', 'Sublingual - Rectal - Oral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Afke van de Plas, Hospital Pharmacist', 'role': 'CONTACT', 'email': 'a.vande.plas@mumc.nl', 'phone': '+31433874733'}, {'name': 'Johannes van Hooff, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Afke van de Plas, Hospital Pharmacist', 'role': 'CONTACT', 'email': 'a.vande.plas@mumc.nl', 'phone': '+31433874733'}], 'overallOfficials': [{'name': 'Johannes van Hooff, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'A. van de Plas / Hospital Pharmacist', 'oldOrganization': 'Maastricht University Hospital'}}}}