Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-04 @ 12:52 AM
Study NCT ID:
NCT00199667
Status:
UNKNOWN
Last Update Posted:
2008-12-16
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 137}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2008-12-14', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).'}], 'secondaryOutcomes': [{'measure': 'renal fonction evolution'}]}, 'conditionsModule': {'keywords': ['MMF, Monitoring, area under curve (AUC), kidney transplantation'], 'conditions': ['Kidney Transplant Recipients']}, 'descriptionModule': {'briefSummary': 'Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA\\<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients received a first or a second kidney transplantation\n* patients with panel reactive antibody \\<or= 50 %\n* patients with cellcept treatment since fewer 3 days\n* patients receiving or being received ciclosporine treatment\n* patients without retention, important hepatic cytolysis\n* patients without post-surgical complication or intercurrent disease\n* informed consent signed\n\nExclusion Criteria:\n\n* patients included in other study\n* patients with MMF or mycophenolic acid hypersensibility or MMF contraindication\n* patients with gastroduodenal disorder before the beginning of the study\n* pregnant women or without contraception\n* patients with rapamycin or analogous\n* patients with toxicomania or psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT00199667', 'briefTitle': 'Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': "APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation", 'orgStudyIdInfo': {'id': 'I02013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mycophenolate Mofetil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51000', 'city': 'Reims', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Néphrologie', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Yann LE MEUR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}]}}}