NCT00188825

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2004

Typical duration for phase_3

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

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

May 3, 2017

Conditions

COPDEmphysemaAlpha-1 Antitrypsan Deficiency

Keywords

LungTransplantRejectionBOS

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.

Secondary Outcomes (1)

  • The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.

Study Arms (2)

basiliximab

EXPERIMENTAL
Drug: basiliximab

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

placeboOTHER
placebo
basiliximabDRUG
basiliximab

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaRejection, Psychology

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Thomas K Waddell, MD FRCSC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Cecilia Chaparro, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

CA(1)