search
Back to results

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

Primary Purpose

COPD, Emphysema, Alpha-1 Antitrypsan Deficiency

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
placebo
basiliximab
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Lung, Transplant, Rejection, BOS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

basiliximab

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
May 3, 2017
Sponsor
University Health Network, Toronto
Collaborators
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00188825
Brief Title
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema, Alpha-1 Antitrypsan Deficiency
Keywords
Lung, Transplant, Rejection, BOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
basiliximab
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
basiliximab
Primary Outcome Measure Information:
Title
The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.
Secondary Outcome Measure Information:
Title
The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas K Waddell, MD FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cecilia Chaparro, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs