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

May 3, 2017 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo
Experimental: basiliximab
Drug: basiliximab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Novartis

Investigators

  • Principal Investigator: Thomas K Waddell, MD FRCSC, University Health Network, Toronto
  • Principal Investigator: Cecilia Chaparro, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHI621AES05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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