- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01663805
Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population
Effects of the Use of "de Novo" Everolimus for the Expression of Cytokines in Kidneys From Extended Criteria Donors and With Delayed Graft Function
This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 80 patients will participate in the study, being distributed into 4 groups of 20 individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive therapy with TAC, no statistical power analysis could be performed a priori.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Mario Abbud, MD.PhD
- Phone Number: 551740099191
- Email: mabbud@terra.com.br
Study Contact Backup
- Name: Amanda Calori
- Phone Number: 551740099167
- Email: estudos@iun.com.br
Study Locations
-
-
São Paulo
-
São José do Rio PReto, São Paulo, Brazil, 15015200
- Recruiting
- Instituto de Urologia e Nefrologia
-
Contact:
- Amanda Calori
- Phone Number: 551740099167
- Email: estudos@iun.com.br
-
Contact:
- Mario Abbud, MD,Phd
- Phone Number: 551740099191
- Email: mabbud@terra.com.br
-
São José do Rio Preto, São Paulo, Brazil, 15015-200
- Recruiting
- Instituto de Urologia e Nefrologia
-
Contact:
- Mario Abbud, MD,Phd
- Phone Number: 551740099191
- Email: mabbud@terra.com.br
-
Contact:
- Amanda Calori
- Phone Number: 551740099191
- Email: estudos@iun.com.br
-
Principal Investigator:
- Mario Abbud, MD,Phd
-
Sub-Investigator:
- Ida Fernandes, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years (black and white subjects);
- 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:
- The subject, in the opinion of the investigator, is not able to complete the study protocol;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Everolimus
SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone
|
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 Names:
|
No Intervention: mycophenolate sodium
SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Molecular profile of cytokines
Time Frame: 12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection
Time Frame: 12 months
|
To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mario Abbud, MD.PhD, Instituto de Urologia e Nefrologia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAD001ABR21T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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