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Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant

NCT ID: NCT02208791

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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Kidney Transplantation Graft Rejection Immunossupression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus/MPS/Prednisone

This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type DRUG

Sirolimus/Low Tacrolimus/MPS/Prednisone

Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid..

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.

Interventions

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Sirolimus

Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.

Intervention Type DRUG

No intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women, ages 18 to 60 years inclusive
* Percentage of Panel Reactive Antibodies at transplantation \> 20%
* Estimated glomerular filtration rate using MDRD formula at inclusion \>29ml/min

Exclusion Criteria

* Subjects with a history of cancer
* Subjects with a previous non kidney transplantation
* Subjects receiving any immunosuppression different of tacrolimus/prednisone/mycophenolate
* Subjects with a urinary protein/creatinine ratio greater than 0.3
* Subjects with active HBV, HCV and HIV infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Nelson Z Galante, PhD

Role: CONTACT

Phone: 55-11-2661-8089

Email: [email protected]

Fabiana Agena, MS

Role: CONTACT

Phone: 55-11-2661-8089

Email: [email protected]

Facility Contacts

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Elias David-Neto, PhD

Role: primary

Nelson Z Galante, PhD

Role: backup

Other Identifiers

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U1111-1157-7462

Identifier Type: -

Identifier Source: org_study_id