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Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072589
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Christine Lau, MD, University of Virginia

Brief Summary:
This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that can be given to people who are having a lung transplant. Regadenoson will be given as a continuous IV infusion. All participants in the study will receive a regadenoson infusion beginning in the operating room during the lung transplant procedure. Participants will be assigned a certain dose of regadenoson to be given over a 12 or 24 hour period.

Condition or disease Intervention/treatment Phase
Lung Transplant Drug: Regadenoson infusion Phase 1

Detailed Description:

Lung transplantation currently is one way to treat a variety of serious diseases and conditions such as emphysema, pulmonary fibrosis, and cystic fibrosis. Ischemia Reperfusion Injury (IRI) is a known problem that can happen during the first few days after a lung transplant. IRI can cause swelling of the lungs and low levels of oxygen. The most serious type of IRI can cause the transplanted lung to not work properly, it can even cause death. While new treatments and practices have been put into place to lower the chances of IRI, it is still a difficult problem to overcome after a lung transplant.

Medicines called Adenosine 2A receptors (A2AR) have been studied in animals with IRI for many years. Some of these studies suggest that with the use of A2AR medicines, the chance of IRI may be lowered or prevented. Regadenoson is an A2AR drug.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open Label Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Experimental: Regadenoson infusion
Dose escalation of Regadenoson infusion
Drug: Regadenoson infusion
Dose escalation of Regadenoson when given as an infusion




Primary Outcome Measures :
  1. Patient tolerability of assigned dose and duration [ Time Frame: Day 7 ]
    Absence of a dose-limiting toxicity


Secondary Outcome Measures :
  1. Activation of iNKT cells [ Time Frame: 24 hours ]
    Activation of iNKT cells

  2. Clinical Pulmonary Graft Dysfunction (PGD) score [ Time Frame: 72 hours ]
    Evaluate for ischemia reperfusion injury

  3. Inflammatory Cytokines in blood and bronchioalveolar lavage [ Time Frame: 24 hours ]
    Inflammatory Cytokines in blood and bronchioalveolar lavage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be undergoing a bilateral lung transplantation for end-stage lung disease and thus meet all criteria to be listed
  • Male or female subject, 18 -75 years of age
  • Subjects must sign a study specific informed consent prior to study entry
  • Subjects must meet all of the following laboratory values:

    1. hemoglobin ≥ 6 g/dL,
    2. platelets > 75,000/mcL,
    3. aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT /SGPT) < 2.5 X institutional upper limit of normal,
    4. serum creatinine < 1.5 mg/dL,
    5. INR < 1.5, PTT < 40 seconds

Exclusion Criteria:

  • Subject requires preoperative extracorporeal membrane oxygenation (ECMO)
  • Subject has second degree (Mobitz type I or II) or third-degree AV block or sinus node dysfunction
  • Subject has history of a bleeding diathesis
  • Subject has a history of clinically overt stroke within the past 3 years
  • Subject has a history of severe hypertension not adequately controlled with anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg)
  • Subjects who are receiving chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable)
  • Subjects with a history of metastatic cancer
  • Subjects with a history of seizure disorder
  • Subjects who are receiving or have received within 30 days any other investigational agents
  • Subjects who have received theophylline or aminophylline within 12 hours of study dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072589


Contacts
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Contact: Amanda Bartosic, MBA 410-328-1641 ABartosic@som.umaryland.edu
Contact: Jennifer Phillips, RN 434-243-5435 jvp8a@virginia.edu

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Amanda Bartosic, MBA    410-328-1641    ABartosic@som.umaryland.edu   
Principal Investigator: Christine Lau, MD         
United States, Virginia
University of Virginia Active, not recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Christine Lau, MD
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christine Lau, MD University of Maryland, Baltimore
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Responsible Party: Christine Lau, MD, Surgeon-in-Chief, Department of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT03072589    
Other Study ID Numbers: UVA-LAU-01
1R01HL128492-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs