Text Size

AIRSAC Trial - Comparison of a Tacrolimus/Sirolimus/Prednisone Regimen Versus Tacrolimus/Azathioprine/Prednisone Immunosuppressive Regimen in Lung Transplantation

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma Inc
Loyola University
University of Florida
University of Pennsylvania
Baylor College of Medicine
Ochsner Health System
Columbia University
University of Wisconsin, Madison
Information provided by (Responsible Party):
Edward Garrity, University of Chicago
ClinicalTrials.gov Identifier:
NCT00321906
First received: May 2, 2006
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.


Condition Intervention Phase
Delayed Graft Function
Graft Rejection
 Drug: azathioprine
Drug: sirolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of a Tacrolimus/Sirolimus/Prednisone Regimen Versus Tacrolimus/Azathioprine/Prednisone Immunosuppressive Regimen in Lung Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To compare the efficacy of a sirolimus regimen with an azathioprine regimen in reducing the incidence of acute rejection and chronic rejection during the first twelve months after lung transplantation [ Time Frame: 12mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the incidence of serious adverse events including infection, toxicity (hyperlipidemia, leukopenia, thrombocytopenia, renal insufficiency, etc.), malignancy, and drug interactions between the two immunosuppressive regimens [ Time Frame: 36 mos ] [ Designated as safety issue: Yes ]
  • To compare the time to acute rejection and the severity of acute rejection at 12 months between both groups [ Time Frame: 12 mos ] [ Designated as safety issue: Yes ]
  • To compare graft function as assessed by forced expiratory volume in one second (FEV1) and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75) at 24 and 36 months between both groups [ Time Frame: 36mos ] [ Designated as safety issue: No ]
  • To compare the incidence of chronic rejection or bronchiolitis obliterans syndrome (BOS) at 24 and 36 months between both groups [ Time Frame: 36 mos ] [ Designated as safety issue: No ]
  • To compare patient survival at 12, 24, and 36 months between both groups [ Time Frame: 36 mos ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: April 2002
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
(tacrolimus,azathioprine/prednisone)
 Drug: azathioprine
azathioprine 2mg/kg
Active Comparator: 2
tacrolimus/sirolimus/prednisone
 Drug: sirolimus
sirolimus 2-4mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lung transplant recipients between the age of 18 and 65 years of age.
  • Females who are capable of becoming pregnant must have a negative pregnancy test prior to consent. (Females of childbearing potential must be using a medically acceptable method of birth control for the duration of the study.)
  • All patients must be able to give written informed consent.

Exclusion Criteria:

  • White blood cell count (WBC) < 4.0/mm3
  • Platelet count < 100,000/mm3
  • Severe hypercholesterolemia (> 350 mg/dl) or hypertriglyceridemia (> 500 mg/dl)
  • Uncontrolled systemic infection at the time of consent.
  • Previous organ transplant
  • Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry or for the duration of the study (3 years).
  • Use of maintenance immunosuppression other than daclizumab, tacrolimus, azathioprine, or prednisone prior to randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321906

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Astellas Pharma Inc
Loyola University
University of Florida
University of Pennsylvania
Baylor College of Medicine
Ochsner Health System
Columbia University
University of Wisconsin, Madison
Investigators
Principal Investigator: Edward Garrity, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edward Garrity, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00321906     History of Changes
Other Study ID Numbers: 14467B
Study First Received: May 2, 2006
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Rejection in lung transplant

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes
Azathioprine
Immunosuppressive Agents
Sirolimus
Everolimus
Tacrolimus
Prednisone
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013