Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 6:45 PM
Study NCT ID:
NCT00707759
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2008-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'madelucchi@gmail.com', 'phone': '56-2-25755972', 'title': 'Maria Angela Delucchi', 'organization': 'FONDECYT'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'A: Withdrawal Steroids', 'description': 'Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B: Control Steroids', 'description': 'Arms B: TAC + MMF + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stimulation of Growth After 12 Months (Delta Z-score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Withdrawal Steroids', 'description': 'Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone'}, {'id': 'OG001', 'title': 'B: Control Steroids', 'description': 'Arms B: TAC + MMF + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A: Withdrawal Steroids', 'description': 'Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone'}, {'id': 'FG001', 'title': 'B: Control Steroids', 'description': 'Arms B: TAC + MMF + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A: Withdrawal Steroids', 'description': 'Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone'}, {'id': 'BG001', 'title': 'B: Control Steroids', 'description': 'Arms B: TAC + MMF + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d\n\nTacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Chile', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height Z-score', 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '-2.0', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '-2.3', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2008-06-26', 'resultsFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-13', 'studyFirstPostDateStruct': {'date': '2008-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stimulation of Growth After 12 Months (Delta Z-score)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric renal transplantation,Bone metabolism (DXA-pQCT)', 'mRNAFOXP3/IL-17,Steroid withdrawal'], 'conditions': ['Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF). To investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and evaluate the expression of IL17 (interleukin 17) and mRNA FOXP3 (messenger ribonucleic acid forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy).\n\nHypothesis:Steroid withdrawal in renal pediatric transplant patients improves growth and bone metabolism without increasing the risk of acute rejection. The expression of FoxP3/IL17 in urine cells could be an early molecular markers of acute rejection.', 'detailedDescription': 'The intention of this investigation is to evaluate a prospective immunosuppressive protocol based on antibodies anti IL-2 (Ac-IL-2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF)and withdrawal steroids in renal transplant and to compare with a steroid-based protocol.\n\nObjectives:\n\n1. To evaluate growth and the impairment in the GH/IGF (growth hormone/insulin like growth factor) axis\n2. To determine the impact of steroids on bone metabolism (biochemical parameters, DXA and pQCT)\n3. To determine the steroid effect on metabolic factors (dyslipidemia, insulin- sensitivity and arterial hypertension)\n4. To determine acute rejection incidence (protocol renal biopsy)\n5. To evaluate the expression of IL-17 and mRNA FoxP3 as early markers of acute rejection (blood, urine and renal biopsy).\n\nTwo treatment regimes (Arms)will be compared in randomized form in the course of 12 months after transplantation.\n\nArm A: TAC + MMF + withdrawal of steroids over a six-days following randomization.\n\nArm B: TAC + MMF + prednisolone (see schedule)/day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 16.0 years\n* Bone age of boys \\< 15 years, of girls \\< 13 years\n* Prepuberal Tanner Status I\n* First or second kidney transplant, living or deceased kidney donation\n* Immunosuppression with Tacrolimus (TAC),Mycophenolate mofetil (MMF)\n* Patients and parents, respectively, have given their written consent after enlightenment (informed consent)\n\nExclusion Criteria:\n\n* Irreversible rejection of former transplant\n* Highly reactive (\\> 30%) lymphocytotoxic antibodies within 12 months prior to transplantation\n* Suspected insufficient medication compliance in dialysis\n* Patients receiving a basic immunosuppression other than that prescribed in this protocol\n* Simultaneous therapy with growth hormone after renal transplant'}, 'identificationModule': {'nctId': 'NCT00707759', 'briefTitle': 'Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fondo Nacional de Desarrollo Científico y Tecnológico, Chile'}, 'officialTitle': 'Multicenter, Open-Label, Randomized Study on Steroid-Free Immunosuppression, in Comparison With Daily Steroid Therapy, in Pediatric Renal Transplant : Impact on Growth, Bone Metabolism and Acute Rejection', 'orgStudyIdInfo': {'id': 'Fondecyt1080166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: withdrawal steroids', 'description': 'Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone', 'interventionNames': ['Drug: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Arms B: TAC + MMF + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d', 'interventionNames': ['Drug: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone']}], 'interventions': [{'name': 'Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone', 'type': 'DRUG', 'description': 'Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.\n\n1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses\n\n3°day: Prednisone 2 mg/kg/d in 2 doses\n\n4ºday: Prednisone 1 mg/kg/d in 2 doses\n\n5ºday: Prednisone 0.5 mg/kg/d in 2 doses\n\n6ºday: Prednisone 0.25 mg/kg/d in 2 doses\n\n7ºday: Stop Prednisone', 'armGroupLabels': ['A: withdrawal steroids']}, {'name': 'Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone', 'type': 'DRUG', 'description': 'Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day\n\n10°days after Tx: 2 mg/kg/d\n\nDay 11 - 20: 1 mg/kg/d\n\nDay 21 - 30: 0.5 mg/kg/d\n\nDay 31 - 60: 0.3 mg/k/d\n\nWeek 8 - 12: 0.25 mg/k/d\n\nWeek 12 - 16: 0.20 mg/k/d\n\nWeek 16 - 20: 0.15 mg/k/d\n\nMonth 6 - 12: 0.10 - 0.12 mg/k/d', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Metropolitan Region', 'country': 'Chile', 'facility': 'Calvo Mackenna Children Hospital', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Maria Angela Delucchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Calvo Mackenna Children´s Hospital-University of Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondo Nacional de Desarrollo Científico y Tecnológico, Chile', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Maria Angela Delucchi Bicocchi', 'investigatorAffiliation': 'Fondo Nacional de Desarrollo Científico y Tecnológico, Chile'}}}}