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

Status unconfirmed · Phase 1

Conditions studied: Lung Transplant

In brief

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.

Key facts

Study ID

NCT03072589

Run by

Christine Lau, MD

People needed

21

Starts

2017-11-30

Expected to finish

2022-08-01

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Maryland — Baltimore, Maryland, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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