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

NCT01663805 | Unknown Phase 4

• 1 other identifier: CRAD001ABR21T
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Delayed Function of Renal Transplant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection

  12 months

Study Arms (2)

Everolimus

ACTIVE COMPARATOR

SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone

Drug: Everolimus

mycophenolate sodium

NO INTERVENTION

SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone

Interventions

Everolimus DRUG

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.

Also known as: Certican

Everolimus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MARIO ABBUD FILHO: lead

Study Sites (3)

Instituto de Urologia e Nefrologia

São José do Rio Preto, São Paulo, 15015-200, Brazil

RECRUITING

Instituto de Urologia e Nefrologia

São José do Rio Preto, São Paulo, 15015-200, Brazil

RECRUITING

Instituto de Urologia e Nefrologia

São José do Rio Preto, São Paulo, 15015200, Brazil

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Mario Abbud, MD.PhD

  Instituto de Urologia e Nefrologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Abbud, MD.PhD

CONTACT

551740099191; mabbud@terra.com.br

Amanda Calori

CONTACT

551740099167; estudos@iun.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: August 13, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: August 13, 2012

Record last verified: 2012-04

Locations

BR (3)