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

NCT ID: NCT00188825

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-10-31

Brief Summary

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

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.

Conditions

COPD; Emphysema; Alpha-1 Antitrypsan Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

basiliximab

Group Type: EXPERIMENTAL

basiliximab

Intervention Type: DRUG

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

placebo

Intervention Type: OTHER

basiliximab

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas K Waddell, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Cecilia Chaparro, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CCHI621AES05

Identifier Type: -

Identifier Source: org_study_id