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Everolimus in Combination Wit...

Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

Last Updated: 2011-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.

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Detailed Description

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Conditions

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Transplantation Infection

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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Upper everolimus blood target + very low dose cyclosporine

Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.

Group Type EXPERIMENTAL

Everolimus 0.25 and 0.75 mg tablets

Intervention Type DRUG

The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.

Cyclosporine very low dose (150-300 ng/mL) microemulsion

Intervention Type DRUG

The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.

Standard everolimus blood target + low dose cyclosporine

Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.

Group Type ACTIVE_COMPARATOR

Everolimus 0.25 and 0.75 mg tablets

Intervention Type DRUG

Cyclosporine low dose (350-500 ng/mL) microemulsion

Intervention Type DRUG

Interventions

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Everolimus 0.25 and 0.75 mg tablets

Intervention Type DRUG

Cyclosporine very low dose (150-300 ng/mL) microemulsion

Intervention Type DRUG

Cyclosporine low dose (350-500 ng/mL) microemulsion

Intervention Type DRUG

Other Intervention Names

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Neoral Neoral

Eligibility Criteria

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Inclusion Criteria

* Patients with functioning graft who had completed the 6-month treatment period of core study
* Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
* Patients who signed the informed consent of the present study extension