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Clinical Trial Details

Trial ID: L1419
Source ID: NCT01631058
Associated Drug: Everolimus
Title: Renal Transplantation in the Elderly - nEverOld Study
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Renal Failure (CRF)|Graft Failure|Transplant; Failure, Kidney|Renal Transplant Rejection
Interventions: DRUG: Everolimus
Outcome Measures: Primary: Evaluation of functional graft, 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., 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. | Secondary: Pharmacokinetic of Tacrolimus, Pharmacokinetic of Tacrolimus in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant., Days: 7, 30, 60, 67, 90, 180.|Serious adverse events, Evaluate serious adverse events (as internationally defined by ICH-GCP)., Every year, for five years|Biopsy, Biopsy proven acute rejection rated every year, for five years., Every year, for five years|Renal filtration markers, 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., Days: 7, 30, 37, 60, 67, 90, 180. Months: 12, 18, 24, 36, 48, 60|Bone density, Evaluation of bone density at month 12 post-transplant., Month 12|Vitamin D, Evaluation of vitamin D at months 2 and 12 post-transplant., Months: 2, 12.|Gonadal function, Evaluation of gonadal function at months 1 and 12 post-transplant., Months: 1, 12.|Quality of Life, Evaluate Quality of Life at months 1, 12, 18, 24, 36, 48 and 60 post-transplant in the study population., Months: 1, 12, 18, 24, 36, 48, 60.|Left Ventricular Mass (LVM), Left Ventricular Mass (LVM) measured by echocardiography at the end of the first year., Month: 12.|Left Ventricle Ejection Fraction (LVEF), Left Ventricle Ejection Fraction (LVEF) measured by echocardiography at the end of the first year., Month: 12.|Pharmacokinetic of Everolimus, Pharmacokinetic of Everolimus in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant., Days: 7, 30, 60, 67, 90, 180.|Pharmacokinetic of Mycophenolate Sodium, Pharmacokinetic of Mycophenolate Sodium in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant., Days: 7, 30, 60, 67, 90, 180.
Sponsor/Collaborators: Sponsor: University of Sao Paulo General Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 90
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2019-06
Results First Posted:
Last Update Posted: 2015-12-04
Locations: Clinical Hospital of the School of Medicine, University of Sao Paulo, Sao Paulo, SP, 05403900, Brazil|Clinical Hospital of the School of Medicine, University of Sao Paulo, Sao Paulo, SP, 05403900, Brazil
URL: https://clinicaltrials.gov/show/NCT01631058