Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT00141804
Status:
UNKNOWN
Last Update Posted:
2005-12-01
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Sirolimus in Combination With Tacrolimus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 190}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2005-11-30', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- time to first biopsy proven acute rejection episode at month 12'}, {'measure': '- graft failure at month 12'}, {'measure': '- discontinuation of study medication at month 12'}], 'secondaryOutcomes': [{'measure': '- patient and graft survival at month 12'}, {'measure': '- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12'}, {'measure': '- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)'}, {'measure': '- incidence and severity of infections at month 12'}, {'measure': '- incidence of adverse events at month 12'}]}, 'conditionsModule': {'keywords': ['renal transplantation', 'immunosuppression', 'prevention of acute rejection'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation', 'detailedDescription': 'Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first kidney transplantation\n* re-transplantation\n* non-related living donor transplantation\n* patients \\> 18 years\n* patients have given their written consent after being informed\n* female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test\n\nExclusion Criteria:\n\n* related living donation\n* patients with known HIV-anamnesis\n* patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection\n* patients with present malignant disease\n* patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer\n* patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority\n* other reasons which depend on the assessment of the physician'}, 'identificationModule': {'nctId': 'NCT00141804', 'briefTitle': 'Efficacy and Safety of Sirolimus in Combination With Tacrolimus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation', 'orgStudyIdInfo': {'id': 'SirTac 01'}, 'secondaryIdInfos': [{'id': 'contract number DE-02-RG-74'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sirolimus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Heiner H. Wolters, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Proverum GmbH', 'class': 'UNKNOWN'}, {'name': 'KKS Netzwerk', 'class': 'NETWORK'}, {'name': 'Fujisawa GmbH', 'class': 'INDUSTRY'}]}}}