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

Phase 3

Completed

• Conditions: Alpha-1 Antitrypsan Deficiency; COPD; Emphysema
• Interventions: Other: placebo; Drug: basiliximab

• Registration Number: NCT00188825
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
basiliximab	basiliximab	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada