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

Delayed Function of Renal Transplant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01663805
• Other study ID #: CRAD001ABR21T
• Status: Recruiting
• Phase: Phase 4
• First received: April 12, 2012
• Last updated: August 9, 2012
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: April 2012
• Source: Instituto de Urologia e Nefrologia
• Contact: Mario Abbud, MD.PhD
• Phone: 551740099191
• Email: mabbud[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delayed Function of Renal Transplant
• Delayed Graft Function

Intervention

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.

Locations

Country	Name	City	State
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	Instituto de Urologia e Nefrologia	São José do Rio PReto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
MARIO ABBUD FILHO

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular profile of cytokines	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	No
Secondary	Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection	To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival	12 months	No