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Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults

NCT ID: NCT01455649

Last Updated: 2011-10-20

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.

Detailed Description

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The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.

Conditions

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Kidney Transplant Immunosuppression

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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Everolimus

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).

calcineurin inhibitor

Group Type ACTIVE_COMPARATOR

calcineurin inhibitor

Intervention Type DRUG

Group will maintain their initial immunosuppression therapy with calcineurin inhibitor

Interventions

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Everolimus

Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).

Intervention Type DRUG

calcineurin inhibitor

Group will maintain their initial immunosuppression therapy with calcineurin inhibitor

Intervention Type DRUG

Other Intervention Names

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Certican Tacrolimus, Cyclosporin, NeoOral, Prograf

Eligibility Criteria

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Inclusion Criteria

* Patients aged from 18 to 65 years old
* First transplantation recipients
* PRA \< 30%
* Living or cadaveric donor
* Stable renal function
* Patients not pregnant or breastfeeding , where pregnancy is defined as the woman status from conception to gestation conclusion, through a positive beta hCG test (\>5mUI/mL)
* Provided written informed consent form

Exclusion Criteria

* Cadaveric donor with expanded criterion
* Multiple organs transplantation
* Kidney cold ischemia time \> 24 hours
* Severe rejection episode - Banf \>IIA
* Glomerular filtration rate \< 35mL/min
* Presence of hard to treat dyslipidemia - severe hypercholesterolemia (\>350mg/dL) or hypertriglyceridemia (\>500mg/dL)
* Proteinuria \> 800mg/24h
* Patients with history of malignancy of any organic system, treated or not, within 5 years, with or without evidence of local recurrence or metastases, other than localized basal cell carcinoma
* Female with childbearing potential without using a reliable contraceptive method.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deise de Boni Monteiro de Carvalho

OTHER

Sponsor Role lead

Responsible Party

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Deise de Boni Monteiro de Carvalho

Organ Transplant Technical Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Francisco G Miloski, MD

Role: STUDY_CHAIR

Physician

Tereza Matuck, MD

Role: STUDY_CHAIR

Chief of the Nephrology Department

Regina Sousa

Role: STUDY_CHAIR

Head Nurse of The Nephrology Department

Locations

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Hospital federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Deise BM Carvalho, MD

Role: CONTACT

[email protected]
+55 (21) 99876059

Other Identifiers

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CRAD001ABR17T

Identifier Type: -

Identifier Source: org_study_id