Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 7:47 AM
Study NCT ID:
NCT00159159
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-26', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level'}], 'secondaryOutcomes': [{'measure': 'Area under curve of creatinine at 12 months'}, {'measure': 'Cystatin C level at 1, 2, 3, 6 and 12 months'}, {'measure': 'Creatinine clearance at 6 and 12 months'}, {'measure': 'Proteinuria and microalbuminuria at 6 and 12 months'}, {'measure': 'Secondary outcomes include those linked to the immunosuppressive efficacy and tolerance of the treatment: Difference in appearance incidence of acute graft reject and adverse events'}, {'measure': 'Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)'}, {'measure': 'Difference in the evolution of left ventricular function and cardiovascular risk factors between the two groups at 6 and 12 months versus baseline: left ventricular ejection fraction and shortening fraction (echocardiogram)'}, {'measure': 'systolic and diastolic blood pressure'}, {'measure': 'fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides'}]}, 'conditionsModule': {'keywords': ['Cardiac Transplant', 'ciclosporine', 'immunosuppressive'], 'conditions': ['Cardiac Transplantion']}, 'referencesModule': {'references': [{'pmid': '23206408', 'type': 'DERIVED', 'citation': 'Boissonnat P, Gaillard S, Mercier C, Redonnet M, Lelong B, Mattei MF, Mouly-Bandini A, Pattier S, Sirinelli A, Epailly E, Varnous S, Billes MA, Sebbag L, Ecochard R, Cornu C, Gueyffier F. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial. Trials. 2012 Dec 3;13:231. doi: 10.1186/1745-6215-13-231.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose\n\nSecondary Objective:\n\n* To evaluate the immunosuppressive efficacy and tolerance of the treatment\n\nStudy Duration:\n\nTwelve months for each patient\n\nStudy Treatment: Ciclosporine\n\nGroup A: low dose \\>= 130 µg/l \\< T0 ciclosporinemia \\< 200 µg/l; Group B: standard dose \\>= 200 µg/l \\< T0 ciclosporinemia \\< 300 µg/l.\n\nStudy Visits:\n\nOne visit every 15 days, for the first three months; then 1 visit every month, for 6 months; and 1 visit at 9 and 12 months.\n\nAssociated Treatments:\n\n* Mycophenolate (Cellcept®), 3g a day\n* Corticoids, as used for transplanted patients\n\nRandomization: Randomization will occur when it is decided that ciclosporine will be introduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRecipient:\n\n* Males or females, ages \\> 18 \\< 65.\n* First cardiac transplant.\n* Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.\n* Written informed consent.\n\nDonor:\n\n* Cold ischemia duration \\< 6 hours\n\nExclusion Criteria:\n\nRecipient:\n\n* Unstable hemodynamic status at randomization.\n* Patient with assisted circulation, considered unstable.\n* Serum creatinine \\> 250 µmol/l.\n* Nursing or pregnant females.\n* HIV positive.\n* PCR hepatitis C virus (HCV) positive or hepatitis B surface (Hbs) antigen positive (within 6 months prior to study).\n* Multi-organ graft or retransplant.\n* History of cancer (evolving, or within 5 years, except for epidermoid or basocellular localised cutaneous carcinoma).\n* Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.\n* Any substance abuse or any psychiatric disorder\n* Contra-indication to study treatments.\n* Unable to introduce ciclosporine within 4 days after transplant.\n\nDonor:\n\n* Known coronary pathology or cardiac disease.\n* HBsAg positive or HCV positive'}, 'identificationModule': {'nctId': 'NCT00159159', 'briefTitle': 'LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'LOW CYCLO: A Multicenter, Prospective, Randomized Study Evaluating the Benefit, on Renal Function, of Two Doses of Ciclosporine: Low Dose Versus Usual Dose, in Association With Mycophenolate and Corticoïds, in de Novo Cardiac Transplant', 'orgStudyIdInfo': {'id': '2003.325'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l', 'type': 'DRUG'}, {'name': 'Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Lyon', 'country': 'France', 'facility': 'Pascale BOISSONNAT', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Pascale BOISSONNAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}}}}