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

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ClinicalTrials.gov Identifier: NCT00188825
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COPD Emphysema Alpha-1 Antitrypsan Deficiency Other: placebo Drug: basiliximab Phase 3

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: basiliximab Drug: basiliximab
Placebo Comparator: placebo Other: placebo



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188825


Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Novartis
Investigators
Principal Investigator: Thomas K Waddell, MD FRCSC University Health Network, Toronto
Principal Investigator: Cecilia Chaparro, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188825     History of Changes
Other Study ID Numbers: CCHI621AES05
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by University Health Network, Toronto:
Lung
Transplant
Rejection
BOS

Additional relevant MeSH terms:
Bronchiolitis
Emphysema
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pathologic Processes
Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs