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

This study is currently recruiting participants.
Verified April 2012 by Instituto de Urologia e Nefrologia
Sponsor:
Information provided by (Responsible Party):
MARIO ABBUD FILHO, Instituto de Urologia e Nefrologia
ClinicalTrials.gov Identifier:
NCT01663805
First received: April 12, 2012
Last updated: August 9, 2012
Last verified: April 2012

April 12, 2012
August 9, 2012
January 2012
December 2014   (final data collection date for primary outcome measure)
Molecular profile of cytokines [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01663805 on ClinicalTrials.gov Archive Site
Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Delayed Function of Renal Transplant
Drug: 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 Name: Certican
  • Active Comparator: Everolimus
    SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone
    Intervention: Drug: Everolimus
  • No Intervention: mycophenolate sodium
    SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Mario Abbud, MD.PhD 551740099191 mabbud@terra.com.br
Contact: Amanda Calori 551740099167 estudos@iun.com.br
Brazil
 
NCT01663805
CRAD001ABR21T
No
MARIO ABBUD FILHO, Instituto de Urologia e Nefrologia
MARIO ABBUD FILHO
Not Provided
Principal Investigator: Mario Abbud, MD.PhD Instituto de Urologia e Nefrologia
Instituto de Urologia e Nefrologia
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP