Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population

August 9, 2012 updated by: MARIO ABBUD FILHO

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

Unknown

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

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • São Paulo
      • São José do Rio PReto, São Paulo, Brazil, 15015200
        • Recruiting
        • Instituto de Urologia e Nefrologia
        • Contact:
        • Contact:
      • São José do Rio Preto, São Paulo, Brazil, 15015-200
        • Recruiting
        • Instituto de Urologia e Nefrologia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario Abbud, MD,Phd
        • Sub-Investigator:
          • Ida Fernandes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Certican
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mario Abbud, MD.PhD, Instituto de Urologia e Nefrologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

April 1, 2012

More Information

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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