NCT00321906

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

February 4, 2014

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

9.3 years

First QC Date

May 2, 2006

Results QC Date

December 17, 2013

Last Update Submit

September 19, 2016

Conditions

Delayed Graft FunctionAcute Graft Rejection

Keywords

Rejection in lung transplant

Outcome Measures

Primary Outcomes (1)

  • Acute Rejection Rate at 12 Months

    Raw proportion of patients that experienced acute rejection at or before 12 months.

    12mos

Secondary Outcomes (7)

  • Acute Rejection-free Survival at 12 Months

    12 mos

  • Severity of Acute Rejection at 12 Months

    12 mos

  • Bronchiolitis Obliterans Syndrome (BOS) at 24 Months

    24 mos

  • Bronchiolitis Obliterans Syndrome (BOS) at 36 Months

    36 mos

  • Overall Survival at 12 Months

    12 mos

  • +2 more secondary outcomes

Study Arms (2)

Azathioprine

ACTIVE COMPARATOR

(tacrolimus,azathioprine/prednisone)

Drug: azathioprine

Sirolimus

ACTIVE COMPARATOR

tacrolimus/sirolimus/prednisone

Drug: sirolimus

Interventions

azathioprineDRUG

azathioprine 2mg/kg

Azathioprine
sirolimusDRUG

sirolimus 2-4mg daily

Sirolimus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

  • Bhorade S, Ahya VN, Baz MA, Valentine VG, Arcasoy SM, Love RB, Seethamraju H, Alex CG, Bag R, Deoliveira NC, Husain A, Vigneswaran WT, Charbeneau J, Krishnan JA, Durazo-Arvizu R, Norwick L, Garrity E. Comparison of sirolimus with azathioprine in a tacrolimus-based immunosuppressive regimen in lung transplantation. Am J Respir Crit Care Med. 2011 Feb 1;183(3):379-87. doi: 10.1164/rccm.201005-0775OC. Epub 2010 Sep 10.

    PMID: 20833822RESULT

  • Bhorade SM, Husain AN, Liao C, Li LC, Ahya VN, Baz MA, Valentine VG, Love RB, Seethamraju H, Alex CG, Bag R, DeOliveira NC, Vigneswaran WT, Garrity ER, Arcasoy SM. Interobserver variability in grading transbronchial lung biopsy specimens after lung transplantation. Chest. 2013 Jun;143(6):1717-1724. doi: 10.1378/chest.12-2107.

    PMID: 23370547DERIVED

MeSH Terms

Conditions

Delayed Graft Function

Interventions

AzathioprineSirolimus

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesMacrolidesLactones

Results Point of Contact

Title
Edward Garrity, MD
Organization
The University of Chicago
egarrity@uchicago.edu
(773) 834-1119

Study Officials

  • Edward Garrity, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

April 1, 2002

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 21, 2016

Results First Posted

February 4, 2014

Record last verified: 2016-09

Locations

US(1)