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


Phase 4
18 Years
65 Years
Not Enrolling
Both
Delayed Graft Function, Graft Rejection

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

12mos

Safety Issue:

No

Principal Investigator

Edward Garrity, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

14467B

NCT ID:

NCT00321906

Start Date:

April 2002

Completion Date:

August 2011

Related Keywords:

  • Delayed Graft Function
  • Graft Rejection
  • Rejection in lung transplant
  • Delayed Graft Function

Name

Location

University of Chicago Chicago, Illinois  60637