Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2017-01-05

Brief Summary

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This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.

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Detailed Description

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Conditions

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Lung 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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Quadruple low level IS regimen

quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids

Centre specific triple IS regimen

centre specific CNI-based triple drug immunosuppression (IS)

Group Type EXPERIMENTAL

standard therapy

Intervention Type DRUG

centre specific CNI-based triple drug immunosuppression

Interventions

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standard therapy

centre specific CNI-based triple drug immunosuppression

Intervention Type DRUG

Everolimus

quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids

Intervention Type DRUG

Other Intervention Names

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RAD001

Eligibility Criteria

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Inclusion Criteria

* Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment

Exclusion Criteria

* Patients with thrombocytopenia (platelets \<100,000/mm³), with an absolute neutrophil count of \<1,500/mm³ or leucopenia (leucocytes \<3000/mm³), with anemia with Hb \< 8g/dl at time of screening
* Patients with uncontrolled hypercholesterolemia (\> 350 mg/dL; \> 9.1 mmol/L) or hypertriglyceridemia (\> 750 mg/dL; \> 8.5 mmol/L) at time of screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No