Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2025-07-31

Brief Summary

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In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.

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Detailed Description

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Conditions

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Disorder Related to Renal Transplantation

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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standard maintenance immunosuppression

tacrolimus, mycophenolate and prednisone

Group Type ACTIVE_COMPARATOR

standard maintenance immunosuppression

Intervention Type DRUG

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

fourth maintenance immunosuppressive

everolimus, tacrolimus, mycophenolate and prednisone

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

mTORi added as the fourth maintenance immunosuppressive drug in recipients

Interventions

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Everolimus

mTORi added as the fourth maintenance immunosuppressive drug in recipients

Intervention Type DRUG

standard maintenance immunosuppression

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.

Exclusion Criteria

* Obese patients (body mass index above 35 m2);
* History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure;
* Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus;
* Triglyceride levels greater than 300 mg/dl at enrollment;
* Active infection by hepatitis B virus, hepatitis C virus or HIV;
* CMV nonreactive IgG sorology at the time of transplantation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No