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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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188825
First received: September 12, 2005
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
COPD
Emphysema
Alpha-1 Antitrypsan Defficiency
Drug: basiliximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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.

Enrollment: 22
Study Start Date: May 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: basiliximab Drug: basiliximab
Placebo Comparator: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188825     History of Changes
Other Study ID Numbers: CCHI621AES05
Study First Received: September 12, 2005
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 27, 2014