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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188825
• Other study ID #: CCHI621AES05
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 3, 2017
• Start date: May 2004
• Est. completion date: October 2007

Study information

• Verified date: May 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alpha-1 Antitrypsan Deficiency
• Bronchiolitis
• Bronchiolitis Obliterans
• COPD
• Emphysema

Intervention

Other:
• placebo

Drug:
• basiliximab

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.
Secondary	The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.