Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant

Study Overview
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Brief Summary
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The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.

Detailed Description
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The objective of this study is to evaluate the efficacy and safety of basiluximab for the prevention of acute allograft lung rejection when used in addition to Neoral, corticosteroids and azathioprine. Acute rejection episodes will be evaluated during the first 6 months post-transplant. Bronchiolitis obliterans syndrome (BOS) will be evaluated at the end of 1 year after transplant and at additional follow-up visits at 2 and 3 years after transplant.

Official Title
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A Randomized, Double Blind, Placebo Controlled Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans Syndrome in Bilateral Lung and Single Lung Transplant Patients

Conditions
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COPD, Emphysema, Alpha-1 Antitrypsan Deficiency

Intervention / Treatment
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* Other: placebo
* Drug: basiliximab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female recipients of a first bilateral or single lung or lobar allograft who are suitable to receive Neoral/ corticosteroids/ azathioprine/ and Basiliximab (Simulect). Patients greater than 18 years of age. Patients capable of understanding the purposes and risks of the study and who have given informed written consent. Exclusion Criteria: Patients who require immunosuppressive therapy other than the study medications. Patients participating in another (investigational) drug trial or who have participated in such a study within 30 days prior to transplantation. Pregnant mothers, nursing women. Women unwilling to use adequate contraception during and for 3 months after receiving study drug. Patients receiving or requiring other investigational drugs, except antibiotics. Patients with current or past peak panel reactive antibody levels of 25% or greater. Patients with malignancy or history of malignancy other than successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin. Patients with any form of substance abuse or psychiatric disorder which, in the opinion of the investigator, might invalidate patient communication with the clinician(s). Patients who have previously received Simulect.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: basiliximab<br> | Drug: basiliximab<br> <br> |
| Placebo Comparator: placebo<br> | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, Transplant, Rejection, BOS