NCT00181142

Brief Summary

The purpose of this study is to compare outcomes in patients undergoing lung transplantation, using 2 different induction therapies. Primary outcome is survival and secondary outcomes include freedom from infection and freedom from rejection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

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

October 1, 1999

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

5.2 years

First QC Date

September 10, 2005

Last Update Submit

December 21, 2017

Conditions

Patients Active and Listed for Lung Transplantation

Keywords

Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation

Outcome Measures

Primary Outcomes (1)

  • All cause mortality at 2 years.

Secondary Outcomes (2)

  • 1)Freedom from 1st >/= A2 rejection episode and incidence of rejection over the first 2 years post-transplant

  • 2)Freedom from infection

Interventions

ZenapaxDRUG

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients accepted and listed for lung transplantation will be considered for randomization

You may not qualify if:

  • Patients who demonstrate hemodynamic instability, requiring inotropes for greater than 48 hours prior to transplant
  • Severe reperfusion pulmonary edema or primary graft dysfunction requiring FiO2 of \> 50% and PEEP \> 10 cm for greater than 48 hours prior to transplant
  • Preoperative renal insufficiency (CrCl \< 50 gm.d or serum creatinine \> 2.0)
  • Pre-operative panel reactive antibodies PRA
  • Preoperative recipient bacterial or fungal colonization
  • Preoperative antimicrobial suppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Daclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • John V Conte, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

October 1, 1999

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

US(1)