Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01631058
Status:
UNKNOWN
Last Update Posted:
2015-12-04
First Post:
2012-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Transplantation in the Elderly - nEverOld Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D000068338', 'term': 'Everolimus'}, {'id': 'C014635', 'term': 'lactitol'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'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': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of functional graft', 'timeFrame': 'The study is planned to analyze all patients at the end of the fifth year after transplantation. However, an interim analysis will be done at the end of each year.', 'description': 'Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) \\< 50 ml/min at the end of first year after transplantation and every year until the fifth year.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic of Tacrolimus', 'timeFrame': 'Days: 7, 30, 60, 67, 90, 180.', 'description': 'Pharmacokinetic of Tacrolimus in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.'}, {'measure': 'Serious adverse events', 'timeFrame': 'Every year, for five years', 'description': 'Evaluate serious adverse events (as internationally defined by ICH-GCP).'}, {'measure': 'Biopsy', 'timeFrame': 'Every year, for five years', 'description': 'Biopsy proven acute rejection rated every year, for five years.'}, {'measure': 'Renal filtration markers', 'timeFrame': 'Days: 7, 30, 37, 60, 67, 90, 180. Months: 12, 18, 24, 36, 48, 60', 'description': 'Identify which of the renal filtration markers existing today, Cystatin C or Serum Creatinine, is more adequate to monitor renal function in elderly transplant and to develop abbreviated equations for eGFR from day 7 on.'}, {'measure': 'Bone density', 'timeFrame': 'Month 12', 'description': 'Evaluation of bone density at month 12 post-transplant.'}, {'measure': 'Vitamin D', 'timeFrame': 'Months: 2, 12.', 'description': 'Evaluation of vitamin D at months 2 and 12 post-transplant.'}, {'measure': 'Gonadal function', 'timeFrame': 'Months: 1, 12.', 'description': 'Evaluation of gonadal function at months 1 and 12 post-transplant.'}, {'measure': 'Quality of Life', 'timeFrame': 'Months: 1, 12, 18, 24, 36, 48, 60.', 'description': 'Evaluate Quality of Life at months 1, 12, 18, 24, 36, 48 and 60 post-transplant in the study population.'}, {'measure': 'Left Ventricular Mass (LVM)', 'timeFrame': 'Month: 12.', 'description': 'Left Ventricular Mass (LVM) measured by echocardiography at the end of the first year.'}, {'measure': 'Left Ventricle Ejection Fraction (LVEF)', 'timeFrame': 'Month: 12.', 'description': 'Left Ventricle Ejection Fraction (LVEF) measured by echocardiography at the end of the first year.'}, {'measure': 'Pharmacokinetic of Everolimus', 'timeFrame': 'Days: 7, 30, 60, 67, 90, 180.', 'description': 'Pharmacokinetic of Everolimus in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.'}, {'measure': 'Pharmacokinetic of Mycophenolate Sodium', 'timeFrame': 'Days: 7, 30, 60, 67, 90, 180.', 'description': 'Pharmacokinetic of Mycophenolate Sodium in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney transplantation', 'chronic renal failure', 'immunosuppressive therapy', 'elderly', 'pharmacokinetic', 'tacrolimus', 'everolimus', 'mycophenolate sodium', 'serious adverse events', 'biopsy', 'Cystatin C', 'metabolic effects', 'Left Ventricular Mass (LVM)', 'Left Ventricle Ejection Fraction'], 'conditions': ['Chronic Renal Failure (CRF)', 'Graft Failure', 'Transplant; Failure, Kidney', 'Renal Transplant Rejection']}, 'referencesModule': {'references': [{'pmid': '30229398', 'type': 'DERIVED', 'citation': 'Romano P, Agena F, de Almeida Rezende Ebner P, Massakazu Sumita N, Kamada Triboni AH, Ramos F, Dos Santos Garcia M, Coelho Duarte NJ, Brambate Carvalhinho Lemos F, Zocoler Galante N, David-Neto E. Longitudinal Pharmacokinetics of Mycophenolic Acid in Elderly Renal Transplant Recipients Compared to a Younger Control Group: Data from the nEverOld Trial. Eur J Drug Metab Pharmacokinet. 2019 Apr;44(2):189-199. doi: 10.1007/s13318-018-0506-6.'}]}, 'descriptionModule': {'briefSummary': 'An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.\n\nTo evaluate the pharmacokinetics of immunosuppressants that have been little studied in this population.\n\nTo evaluate whether the polymorphism of the genes that determine the expression of metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the younger population, absorption and metabolism of immunosuppressants.\n\nTo evaluate the potential minimization of immunosuppression in this population refers to how does the re-population of peripheral lymphocytes, in this age group, after the use of lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two regimes.\n\nClarify which markers of renal filtration exist today, cystatin C and serum creatinine, is the right to monitor renal function in elderly transplanted.', 'detailedDescription': 'Objectives: The objective of this study is to evaluate the safety and efficacy of everolimus (EVL) combined with low dose of Tacrolimus in comparison with Mycophenolate Sodium (MPS) combined with standard dose of Tacrolimus as immunosuppressive therapy for elderly recipients of kidney transplantation.\n\nComparison between the two study arms of:\n\nPrimary Objective:\n\n1\\. Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) \\< 50 ml/min at the end of first year after transplantation and every year until the fifth year.\n\nSecondary Objectives:\n\n1. Pharmacokinetic study of immunosuppressive drugs (Tacrolimus, Everolimus and Mycophenolate Sodium) in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.\n2. Serious adverse events (as internationally defined by ICH-GCP) every year, for five years.\n3. Biopsy proven acute rejection rated every year, for five years.\n4. Identify which of the renal filtration markers existing today, Cystatin C or Serum Creatinine, is more adequate to monitor renal function in elderly transplant and to develop abbreviated equations for eGFR from day 7 on.\n5. Evaluation of other metabolic effects (bone density at month 12 post-transplant; vitamin D at months 2 and 12 post-transplant; and gonadal function at months 1 and 12 post-transplant) and Quality of Life at months 1, 12, 18, 24, 36, 48 and 60 post-transplant in the study population.\n6. Left Ventricular Mass (LVM) and Left Ventricle Ejection Fraction (LVEF) measured by echocardiography at the end of the first year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All renal (only) male and female recipients aged ≥ 60, years undergoing kidney transplantation from a living or deceased donor, including Expanded Criteria Donors (ECD).\n* Panel Reactive Antibody (PRA) \\< 30%.\n* Patients who consented to participate in the study by signing the informed consent form before the transplant surgery to the 1st post-operative day).\n\nExclusion Criteria:\n\n* Allergy to any of proposed medications\n* Patients with any active infection including HBV, HCV and HIV.'}, 'identificationModule': {'nctId': 'NCT01631058', 'briefTitle': 'Renal Transplantation in the Elderly - nEverOld Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study', 'orgStudyIdInfo': {'id': '26423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus', 'description': 'Number of patients: 45 Everolimus: initial dose of 1 mg BID. Doses will be adjusted in order to maintain Everolimus whole blood trough concentrations between 3-8 ng/ml.\n\nTacrolimus: initial dose of 0.1 mg/kg/day. Doses will be adjusted in order to maintain Tacrolimus whole blood trough concentrations between 2- 4 ng/ml thereafter.\n\nCorticosteroids: as clinical practice.', 'interventionNames': ['Drug: Everolimus']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Certican (NOVARTIS)', 'Myfortic (NOVARTIS)', 'Prednisone (generic)'], 'description': 'This is a 5-years prospective, randomized, exploratory, single-center, parallel group trial that includes renal transplanted elderly patients (≥ 60 years old) randomized between months 1 and 3 after transplantation to be maintained under MPS/TAC regimen or be switched to EVL/low-TAC.\n\nEverolimus: initial dose of 1 mg BID. Doses will be adjusted in order to maintain Everolimus whole blood trough concentrations between 3-8 ng/ml.\n\nTacrolimus: initial dose of 0.1 mg/kg/day. Doses will be adjusted in order to maintain Tacrolimus whole blood trough concentrations between 2- 4 ng/ml thereafter.\n\nCorticosteroids: as clinical practice.', 'armGroupLabels': ['Everolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403900', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Elias David-Neto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francine B. Lemos, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nelson Z. Galante, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabiana Agena, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William C Nahas, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wilson Jacob-Filho, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcelo Altona, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daisa R David, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Flavio J Paula, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paschoalina Romano, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Persio AR Ebner, Biol', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria da Luz Fernandes, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Veronica PC Coelho, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Venceslau A Coelho, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabio Di Nizio, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Hospital of the School of Medicine, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403900', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Elias David-Neto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francine B. Lemos, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nelson Z. Galante, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabiana Agena, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Hospital of the School of Medicine, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Elias David-Neto, PhD', 'role': 'CONTACT', 'email': 'elias@cntt.com.br', 'phone': '+55 11 26618089'}], 'overallOfficials': [{'name': 'Elias David-Neto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Hospital of the School of Medicine, University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}