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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Delayed Function of Renal Transplant
 Drug: Everolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of the Use of "de Novo" Everolimus for the Expression of Cytokines in Kidneys From Extended Criteria Donors and With Delayed Graft Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Urologia e Nefrologia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Everolimus
SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone
 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
No Intervention: mycophenolate sodium
SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663805

Contacts
Contact: Mario Abbud, MD.PhD 551740099191 mabbud@terra.com.br
Contact: Amanda Calori 551740099167 estudos@iun.com.br

Locations
Brazil
Instituto de Urologia e Nefrologia Recruiting
São José do Rio Preto, São Paulo, Brazil, 15015-200
Contact: Mario Abbud, MD.PhD     551740099191     mabbud@terra.com.br    
Contact: Amanda Calori     551740099167     estudos@iun.com.br    
Principal Investigator: Mario Abbud, MD.PhD            
Instituto de Urologia e Nefrologia Recruiting
São José do Rio PReto, São Paulo, Brazil, 15015200
Contact: Mario Abbud, MD,Phd     551740099191     mabbud@terra.com.br    
Contact: Amanda Calori     551740099167     estudos@iun.com.br    
Instituto de Urologia e Nefrologia Recruiting
São José do Rio Preto, São Paulo, Brazil, 15015-200
Contact: Mario Abbud, MD,Phd     551740099191     mabbud@terra.com.br    
Contact: Amanda Calori     551740099191     estudos@iun.com.br    
Principal Investigator: Mario Abbud, MD,Phd            
Sub-Investigator: Ida Fernandes, MD            
Sponsors and Collaborators
MARIO ABBUD FILHO
Investigators
Principal Investigator: Mario Abbud, MD.PhD Instituto de Urologia e Nefrologia
  More Information

No publications provided

Responsible Party: MARIO ABBUD FILHO, Principal Investigator, Instituto de Urologia e Nefrologia
ClinicalTrials.gov Identifier: NCT01663805     History of Changes
Other Study ID Numbers: CRAD001ABR21T
Study First Received: April 12, 2012
Last Updated: August 9, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Urologia e Nefrologia:
Extended Criteria Donor
Delayed Graft Function
DGF
Deceased donors aged ≥ 60 years
 aged between 50 and 59 years
history of systemic hypertension
terminal creatinine levels > 1.5 mg/dL
death by a cerebrovascular accident

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013