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

Lung Transplant Clinical Trial

Official title:

A Phase 1 Open Label Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03072589
• Other study ID #: UVA-LAU-01
• Secondary ID: 1R01HL128492-01A
• Status: Recruiting
• Phase: Phase 1
• Start date: November 30, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2020
• Source: University of Virginia
• Contact: Amanda Bartosic, MBA
• Phone: 410-328-1641
• Email: ABartosic[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant

Intervention

Drug:
• Regadenoson infusion
Dose escalation of Regadenoson when given as an infusion

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Christine Lau, MD	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient tolerability of assigned dose and duration	Absence of a dose-limiting toxicity	Day 7
Secondary	Activation of iNKT cells	Activation of iNKT cells	24 hours
Secondary	Clinical Pulmonary Graft Dysfunction (PGD) score	Evaluate for ischemia reperfusion injury	72 hours
Secondary	Inflammatory Cytokines in blood and bronchioalveolar lavage	Inflammatory Cytokines in blood and bronchioalveolar lavage	24 hours