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

Primary Purpose

Delayed Function of Renal Transplant

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Everolimus

About this trial

This is an interventional treatment trial for Delayed Function of Renal Transplant focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto de Urologia e NefrologiaRecruiting
Instituto de Urologia e NefrologiaRecruiting
Instituto de Urologia e NefrologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Everolimus

mycophenolate sodium

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01663805

First Posted

April 12, 2012

Last Updated

August 9, 2012

Sponsor

MARIO ABBUD FILHO

1. Study Identification

Unique Protocol Identification Number

NCT01663805

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

MARIO ABBUD FILHO

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Everolimus

Arm Type

Active Comparator

Arm Description

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

Arm Title

mycophenolate sodium

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

Certican

Intervention Description

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.

Primary Outcome Measure Information:

Title

Molecular profile of cytokines

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mario Abbud, MD.PhD

Phone

551740099191

mabbud@terra.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Amanda Calori

Phone

551740099167

estudos@iun.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Abbud, MD.PhD

Organizational Affiliation

Instituto de Urologia e Nefrologia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Urologia e Nefrologia

City

São José do Rio Preto

State/Province

São Paulo

ZIP/Postal Code

15015-200

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario Abbud, MD.PhD

Phone

551740099191

mabbud@terra.com.br

First Name & Middle Initial & Last Name & Degree

Amanda Calori

Phone

551740099167

estudos@iun.com.br

First Name & Middle Initial & Last Name & Degree

Mario Abbud, MD.PhD

Facility Name

Instituto de Urologia e Nefrologia

City

São José do Rio Preto

State/Province

São Paulo

ZIP/Postal Code

15015-200

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario Abbud, MD,Phd

Phone

551740099191

mabbud@terra.com.br

First Name & Middle Initial & Last Name & Degree

Amanda Calori

Phone

551740099191

estudos@iun.com.br

First Name & Middle Initial & Last Name & Degree

Mario Abbud, MD,Phd

First Name & Middle Initial & Last Name & Degree

Ida Fernandes, MD

Facility Name

Instituto de Urologia e Nefrologia

City

São José do Rio PReto

State/Province

São Paulo

ZIP/Postal Code

15015200

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario Abbud, MD,Phd

Phone

551740099191

mabbud@terra.com.br

First Name & Middle Initial & Last Name & Degree

Amanda Calori

Phone

551740099167

estudos@iun.com.br

12. IPD Sharing Statement

Learn more about this trial

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

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