CompletedNCT00105183Updated Jun 11, 2012Results posted

EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection

A Phase 3 interventional study of Placebo and EZ-2053 in Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis and Cystic Fibrosis, sponsored by Neovii Biotech. Completed at 19 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-11.

Sponsored by Neovii Biotech · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 223
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or lungs.

Read the detailed description

Patients are generally consented for the study once they go on the lung transplant waiting list and then are re-consented periodically thereafter until they undergo the lung transplant surgery. A pre-surgical assessment consisting of medical history, physical exam, ECG, chest X-Ray, and blood tests are conducted. After lung transplant surgery, patients are assessed for continued eligibility. Within 6-24 hours after the end of surgery, patients are randomized to receive one infusion of study drug or placebo through a central venous catheter. Each day for 5 days following transplant surgery, patients are monitored for transplant rejection, infections, adverse events and laboratory test changes. On post-randomization Days 14, 30, 60, 90, 180, 270 and 365, patients will be monitored for acute transplant rejection, infections and cancer, pulmonary function tests and adverse experiences. Pulmonary biopsies will be performed on post-randomization Days 30, 60, 90, 180 and 365. Blood samples will be drawn during each visit.

Conditions studied

Chronic Obstructive Pulmonary
Idiopathic Pulmonary Fibrosis
Cystic Fibrosis
Bronchiectasis
Pulmonary Vascular Disease

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Keywords

pulmonary transplantation
Pulmonary Allograft Rejection

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 223 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Neovii Biotech is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Recipient of a primary single or double pulmonary allograft
Capable of understanding the purposes and risks of the study and has given written informed consent, and agrees to comply with the study requirements
Women of childbearing potential must have a negative serum pregnancy test within 4 days prior to randomization.

Exclusion criteria

Exclusion Criteria:

Undergoing second or living donor transplant
Prior treatment with T-cell depleting agents within the previous 5 years for the purpose of immunosuppression
Prior plasma exchange and/or treatment with IVIg within the past 5 years
Pulmonary infection with pan-resistant Pseudomonas or any Burkholderia species
Known positive blood cultures
Donor lung ischemia time > 8 hours for first lung and > 8 hours for the second lung
Previously received or is receiving a multi-organ transplant
Pregnant women, nursing mothers or women of child-bearing potential who are unwilling to use reliable contraception. Effective contraception must be used BEFORE beginning study drug therapy, for the duration of the study and for 6 months following completion of the study
Active, extra-pulmonary systemic infection requiring the prolonged or chronic use of antimicrobial agents or the presence of a chronic active hepatitis B or C
Active liver disease (liver function tests greater than or equal to 2 times the upper limit of normal)
Severe anemia (hemoglobin, \< 6 g/dL), leukopenia (WBC \< 2500/mm3), thrombocytopenia (platelet count \< 80,000/mm3), polycythemia (Hct > 54% [male], Hct > 49% [female]) or clinically significant coagulopathy
Recipient or donor is seropositive for HIV
Previous exposure or known contraindication to administration of the study drug or to rabbit proteins
Current malignancy or a history of malignancy (within the previous 5 years), except non-metastatic basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully
Unstable cardiovascular disease, or a myocardial infarction within the previous 6 months
Currently participating in another clinical trial with an investigational agent and/or is taking or has been taking an investigational agent in the 30 days prior to transplant and/or has not recovered from any reversible side effects of prior investigational drug
Unlikely to comply with visits schedule in the protocol
Any current history of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 223 participants (actual)

Study arms

Active comparator
EZ-2053
Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
Biological: EZ-2053
Placebo comparator
Placebo
USP 0.9% sodium chloride solution
Biological: Placebo
Active comparator
EZ-2053 5mg/kg
Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Biological: EZ-2053 5mg/kg

Interventions

BiologicalPlacebo
placebo infusion, single
Also known as: Saline
BiologicalEZ-2053
single IV infusion, 9 mg/kg
Also known as: ATG, Anti-human-T-Lymphocyte Immune Globulin, Rabbit
BiologicalEZ-2053 5mg/kg
single IV infusion, 5mg/kg
Also known as: ATG, Anti-human-T-Lymphocyte Immune Globulin, Rabbit

What researchers measure

Primary outcomes

Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)
Time frame: 12 months

Secondary outcomes

Number of Participants With Death or Graft Loss Post-transplant
Time frame: 12 months
Number of Participants With Acute Rejection
Time frame: 12 months
Number of Participants With Infections and Infestations
Time frame: 12 months
Number of Participants With Severe Adverse Events
Time frame: 12 months
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test
Time frame: 12 months
Pulmonary Function Test, Forced Vital Capacity
Time frame: 12 months
Pulmonary Function Test, Forced Expiratory Volume in 1 Second
Time frame: 12 months
Pulmonary Function Test, Forced Expiratory Flow 25-75
Time frame: 12 months

Results

Posted Jun 8, 2012

Limitations and caveats

Interim analysis: Dropped 5mg/kg arm. Study was insufficiently powered \& focus shifted to safety endpoints. Eliminated some secondary endpoints eg. steroid resistant\&antibody treated rejection,CNI\&antiproliferative agent, bronchiolitis obliterans.

Participant flow

Participant flow — Overall Study
Milestone	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Started	82	79	62
Completed	60	60	39
Not completed	22	19	23
Withdrew: Death	19	13	15
Withdrew: Withdrawal by subject	1	1	4
Withdrew: Physician decision	1	2	3
Withdrew: Lost to follow-up	0	1	1
Withdrew: Other reason	1	2	0

Outcome measures

PrimaryNumber of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)

Time frame:: 12 months
Reported as:: Number · participants

Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)
participants	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)	33	29	30

SecondaryNumber of Participants With Death or Graft Loss Post-transplant

Time frame:: 12 months
Reported as:: Number · participants

Number of Participants With Death or Graft Loss Post-transplant
participants	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Number of Participants With Death or Graft Loss Post-transplant	13	8	7

SecondaryNumber of Participants With Acute Rejection

Time frame:: 12 months
Reported as:: Number · participants

Number of Participants With Acute Rejection
participants	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Number of Participants With Acute Rejection	22	20	22

SecondaryNumber of Participants With Infections and Infestations

Time frame:: 12 months
Reported as:: Number · participants

Number of Participants With Infections and Infestations
participants	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Number of Participants With Infections and Infestations	75	70	57

SecondaryNumber of Participants With Severe Adverse Events

Time frame:: 12 months
Reported as:: Number · participants

Number of Participants With Severe Adverse Events
participants	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Number of Participants With Severe Adverse Events	18	14	9

SecondaryPulmonary Function Tests, Total Distance Walked 6 Minute Walk Test

Time frame:: 12 months
Reported as:: Median · Meters

Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test
Meters	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test	457.0 (122.0 to 714.0)	448.0 (278.0 to 674.2)	427.0 (0.0 to 757.0)

SecondaryPulmonary Function Test, Forced Vital Capacity

Time frame:: 12 months
Reported as:: Median · Liters

Pulmonary Function Test, Forced Vital Capacity
Liters	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Pulmonary Function Test, Forced Vital Capacity	3.0 (1.3 to 6.2)	2.9 (1.0 to 5.1)	3.3 (1.0 to 5.4)

SecondaryPulmonary Function Test, Forced Expiratory Volume in 1 Second

Time frame:: 12 months
Reported as:: Median · Liters

Pulmonary Function Test, Forced Expiratory Volume in 1 Second
Liters	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Pulmonary Function Test, Forced Expiratory Volume in 1 Second	2.3 (0.8 to 4.9)	2.3 (0.6 to 4.4)	2.5 (0.8 to 5.1)

SecondaryPulmonary Function Test, Forced Expiratory Flow 25-75

Time frame:: 12 months
Reported as:: Median · Liters/second

Pulmonary Function Test, Forced Expiratory Flow 25-75
Liters/second	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Pulmonary Function Test, Forced Expiratory Flow 25-75	2.7 (0.3 to 7.4)	2.2 (0.3 to 9.3)	2.6 (0.5 to 8.0)

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
EZ-2053 9mg/kg	—	65/82 (79.3%)	82/82 (100%)
Placebo	—	52/78 (66.7%)	78/78 (100%)
EZ-2053 5mg/kg	—	44/61 (72.1%)	61/61 (100%)

Most frequent serious events

Showing 10 of 234

Most frequent serious events
Event	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
Lung transplant rejectionImmune system disorders	9/82	11/78	7/61
Respiratory failureRespiratory, thoracic and mediastinal disorders	6/82	7/78	7/61
PneumoniaInfections and infestations	4/82	6/78	6/61
Pleural effusionRespiratory, thoracic and mediastinal disorders	7/82	4/78	4/61
HypotensionVascular disorders	7/82	2/78	1/61
Lung infection pseudomonalInfections and infestations	4/82	4/78	5/61
PneumothoraxRespiratory, thoracic and mediastinal disorders	6/82	3/78	4/61
Renal failure acuteRenal and urinary disorders	4/82	3/78	4/61
DyspnoeaRespiratory, thoracic and mediastinal disorders	5/82	3/78	0/61
Respiratory distressRespiratory, thoracic and mediastinal disorders	4/82	3/78	3/61

Most frequent other events

Showing 10 of 170

Most frequent other events
Event	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg
DiarrhoeaGastrointestinal disorders	32/82	46/78	20/61
AnaemiaBlood and lymphatic system disorders	48/82	42/78	27/61
NauseaGastrointestinal disorders	44/82	45/78	30/61
Pleural effusionRespiratory, thoracic and mediastinal disorders	41/82	36/78	27/61
Oedema peripheralGeneral disorders	39/82	33/78	29/61
PneumothoraxRespiratory, thoracic and mediastinal disorders	38/82	35/78	23/61
ConstipationGastrointestinal disorders	25/82	35/78	19/61
Lung transplant rejectionImmune system disorders	28/82	33/78	27/61
ThrombocytopeniaBlood and lymphatic system disorders	34/82	10/78	17/61
HypotensionVascular disorders	26/82	25/78	23/61

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg	Total
<=18 years	0	0	0	0
Between 18 and 65 years	78	68	58	204
>=65 years	4	11	4	19

Sex: Female, Male
Sex: Female, Male(Participants)	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg	Total
Female	36	36	27	99
Male	46	43	35	124

Region of Enrollment
Region of Enrollment(participants)	EZ-2053 9mg/kg	Placebo	EZ-2053 5mg/kg	Total
United States	45	41	36	122
Canada	5	5	5	15
Austria	18	18	14	50
Australia	14	15	7	36

Study locations

19 sites

Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
University of California, San Francisco
San Francisco, California 94143, United States
Stanford University
Stanford, California 94305, United States
Mayo Clinic
Jacksonville, Florida 32224, United States
Emory University School of Medicine
Atlanta, Georgia 30322, United States
University of Iowa Hospital & Clinics
Iowa City, Iowa 52242, United States
University of Kentucky Medical Center
Lexington, Kentucky 40536, United States
Barnes-Jewish Hospital
St. Louis, Missouri 63110, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma 73112, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania 19140, United States
Vanderbilt University
Nashville, Tennessee 37232, United States
Baylor College of Medicine
Houston, Texas 77030, United States
University of Texas Health Sciences Center
San Antonio, Texas 78229, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Medical University of Vienna
Vienna, Austria
University of Alberta
Edmonton, Alberta, Canada
Toronto General Hospital
Toronto, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00105183
Lead sponsor: Neovii Biotech
Responsible party: Sponsor
First posted: Mar 9, 2005
Start date: Jan 2005
Primary completion: Jan 2010
Completion: Jan 2011
Results posted: Jun 8, 2012
Last update: Jun 11, 2012

Study contacts

Elbert P Trulock III, MD

principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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