Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-25 @ 4:04 AM
Study NCT ID:
NCT00309218
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2006-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2006-03-30', 'studyFirstSubmitQcDate': '2006-03-30', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients who were deprived of steroids successfully', 'timeFrame': '24 months'}, {'measure': 'Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months', 'timeFrame': '24 months'}, {'measure': 'Incidence and severity of steroid side effects', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric renal transplantation', 'Steroid withdrawal', 'Mycophenolate Mofetil', 'Cyclosporine A', 'Stable graft function', 'children', 'renal transplantation'], 'conditions': ['Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.', 'detailedDescription': 'The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):\n\nBranch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization\n\nBranch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day\n\nAfter two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 18.0 years\n* Bone age of boys \\< 15 years, of girls \\< 13 years\n* Patients 12-24 months after renal transplantation with stable transplant function\n* First or second kidney transplant, living or cadaver kidney donation\n* Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry\n* Patients and parents, respectively, have given their written consent after enlightenment (informed consent)\n\nExclusion Criteria:\n\n* Irreversible rejection of former transplant within 6 months\n* Highly reactive (\\> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation\n* Anamnestically steroid-resistant rejection of current transplant\n* More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry\n* Glomerular filtration rate (GFR) \\< 40 ml/min/1.73 m² (Schwartz formula) at study entry\n* Acute rejection reaction or unstable transplant function (increase of serum creatinine \\> 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction\n* Suspected insufficient medication compliance\n* Patients receiving a basic immunosuppression other than that prescribed in this protocol\n* Simultaneous therapy with growth hormone after renal transplantation'}, 'identificationModule': {'nctId': 'NCT00309218', 'briefTitle': 'Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)', 'organization': {'class': 'OTHER', 'fullName': 'Klinik für Kinder- und Jugendmedizin'}, 'officialTitle': 'Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)', 'orgStudyIdInfo': {'id': 'BToenshoff001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Steroid withdrawal', 'interventionNames': ['Drug: methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'continuos Steroid treatment', 'interventionNames': ['Drug: methylprednisolone']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Burkhard Toenshoff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik für Kinder- und Jugendmedizin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Randomized, multicenter trial on steroid withdrawal in pediatric kidney allograft recipients under CsA and MMF', 'investigatorFullName': 'Dr. med. Britta Hoecker', 'investigatorAffiliation': 'Klinik für Kinder- und Jugendmedizin'}}}}