Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population
NCT ID: NCT01663805
Last Updated: 2012-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2012-01-31
2015-06-30
Brief Summary
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All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.
Detailed Description
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Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk factors: history of systemic hypertension terminal creatinine levels \> 1.5 mg/dL or death by a cerebrovascular accident.
DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after transplantation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Everolimus
SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone
Everolimus
Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.
mycophenolate sodium
SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone
No interventions assigned to this group
Interventions
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Everolimus
Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)
* "Standard" traditional (SCD) or extended criteria (ECD) donor;
* Informed consent form duly signed before SCD or ECD kidney transplantation.
Exclusion Criteria
* Recipient of live-donor kidney graft;
* Multiple organ transplant recipient;
* Evidence of large systemic or localized infection;
* Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;
* Use of any drug under investigation or treatment until up to 4 weeks before transplantation;
* Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;
* Immunosuppressive therapies in addition to those described for this study;
* Hypersensitized patients (PRA \> 30%);
* Patients with HIV+ or Hepatitis B or C virus infection.
* Patients for whom T0 and T15 biopsies were not taken.
18 Years
65 Years
ALL
No
Sponsors
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MARIO ABBUD FILHO
OTHER
Responsible Party
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MARIO ABBUD FILHO
Principal Investigator
Principal Investigators
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Mario Abbud, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Urologia e Nefrologia
Locations
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Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, Brazil
Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, Brazil
Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Mario Abbud, MD.PhD
Role: primary
Amanda Calori
Role: backup
Mario Abbud, MD,Phd
Role: primary
Amanda Calori
Role: backup
Mario Abbud, MD,Phd
Role: primary
Amanda Calori
Role: backup
Other Identifiers
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CRAD001ABR21T
Identifier Type: -
Identifier Source: org_study_id