Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT01892761
Status:
COMPLETED
Last Update Posted:
2013-07-04
First Post:
2013-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MPA Pharmacokinetics in Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-03', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the dynamics of MPA-PK (AUC0-12hrs) during the first six months', 'timeFrame': '6 months', 'description': 'To establish the dynamics of MPA-PK during the first six months following transplantation according to time and the CNI regimen used in 52 patients who had their full MPA-PK monitored in 5 post-transplant time-points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mycophenolate mofetil', 'mycophenolic acid', 'MPA', 'MMF', 'Pharmacokinetics', 'renal transplantation'], 'conditions': ['Kidney Transplantation Recipients']}, 'descriptionModule': {'briefSummary': 'Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both groups but profiles were different according to the CNI regimen and time. The majority of patients were underexposed to MPA on day 7 for both groups what reinforces the need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA monitoring and dose correction for long-term follow-up. These PK data suggest that changes in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific time-points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Renal transplant recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Male and female patients aged 18-65 years, recipients of a non-HLA identical kidney allograft who presented a PRA \\< 50% were eligible for the MoDIFY trial. Subjects were excluded if they received a non-renal organ, had current history of alcohol or illicit drug abuse, had liver enzymes more than two times the upper normal limit or received induction with anti-lymphocyte preparations.'}, 'identificationModule': {'nctId': 'NCT01892761', 'briefTitle': 'MPA Pharmacokinetics in Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'THE PROFILE OF MYCOPHENOLIC ACID IN CONSECUTIVE PHARMACOKINETICS AFTER RENAL TRANSPLANTATION:EFFECTS OF TIME AND CALCINEURIN-INHIBITORS', 'orgStudyIdInfo': {'id': 'CAPPesq 1013/02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TCL/MMF Group', 'interventionNames': ['Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups']}, {'label': 'CyA/MMF Group', 'interventionNames': ['Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups']}], 'interventions': [{'name': 'Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups', 'type': 'DRUG', 'armGroupLabels': ['CyA/MMF Group', 'TCL/MMF Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Renal Transplantation Service', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Elias David-Neto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renal Transplantation Service - Hospital das Clínicas - University of São Paulo School of Medicine, Sao Paulo, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}