NCT03072589

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Christine Lau, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
DRUG	Regadenoson infusion	Dose escalation of Regadenoson when given as an infusion

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-08-01
• Completion: 2022-08-01
• First posted: 2017-03-07
• Last updated: 2020-06-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study