Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 8:54 PM
Study NCT ID:
NCT00359658
Status:
COMPLETED
Last Update Posted:
2009-02-13
First Post:
2006-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-12', 'studyFirstSubmitDate': '2006-08-01', 'studyFirstSubmitQcDate': '2006-08-01', 'lastUpdatePostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal function evaluated by serum creatinine at month 12 and month 24', 'timeFrame': 'month 12 and month 24'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular risk factors at month 12 and month 24', 'timeFrame': 'month 12 and month 24'}, {'measure': 'Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24', 'timeFrame': 'month 12 and month 24'}, {'measure': 'Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24', 'timeFrame': 'month 12 and month 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cyclosporine', 'Glucocorticoids', 'renal insufficiency, chronic', 'long-term care'], 'conditions': ['Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '23454241', 'type': 'DERIVED', 'citation': 'Faulhaber M, Mading I, Malehsa D, Raggi MC, Haverich A, Bara CL. Steroid withdrawal and reduction of cyclosporine A under mycophenolate mofetil after heart transplantation. Int Immunopharmacol. 2013 Apr;15(4):712-7. doi: 10.1016/j.intimp.2013.02.012. Epub 2013 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.', 'detailedDescription': 'The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current immunosuppressive regimen: Cyclosporine A and corticosteroids for at least six month\n* Heart transplantation above 3 years dated back\n* Serum creatinine \\< 3,5 mg/dl (310 µmol/l) and BUN \\< 150 mg/dl\n* Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month\n\nExclusion Criteria:\n\n* Carcinoma within the last 3 years\n* Acute rejection episodes during the last 6 month\n* Infection requiring therapeutic intervention\n* Hepatitis B, Hepatitis C or HIV infection\n* WBC \\< 3000/µl, haemoglobin \\< 9g/dl, platelets \\< 70.000/µl\n* Florid gastrointestinal ulcer\n* Haemodialysis within the last 4 weeks before study entry\n* Pregnancy / lactation\n* Administration of other immunosuppressive agents than prescribed\n* Mycophenolatmofetile incompatibility'}, 'identificationModule': {'nctId': 'NCT00359658', 'briefTitle': 'Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term.', 'orgStudyIdInfo': {'id': 'KKS-94/2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml', 'interventionNames': ['Drug: prednisolon', 'Drug: Mycophenolatmofetile', 'Drug: Cyclosporin A']}], 'interventions': [{'name': 'prednisolon', 'type': 'DRUG', 'otherNames': ['Decortin', 'steroid withdrawal'], 'description': 'prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal', 'armGroupLabels': ['1']}, {'name': 'Mycophenolatmofetile', 'type': 'DRUG', 'otherNames': ['MMF', 'Cellcept'], 'description': 'Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily', 'armGroupLabels': ['1']}, {'name': 'Cyclosporin A', 'type': 'DRUG', 'otherNames': ['Sandimmun optoral'], 'description': 'Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 ng/ml', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School, Department of Thoracic and Cardiovascular Surgery', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Christoph Bara, Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hannover Medical School, Department of Thoracic and Cardiovascular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. med. Chhristoph Bara', 'oldOrganization': 'Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS'}}}}