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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00188825 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00188825 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Cecilia Chaparro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Name:
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Thomas K Waddell, MD FRCSC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alpha-1 Antitrypsan Deficiency
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Emphysema
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COPD
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Intervention(s)
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Drug: basiliximab
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Other: placebo
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Primary Outcome(s)
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The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.
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Secondary Outcome(s)
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The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.
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Secondary ID(s)
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CCHI621AES05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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