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Status unknownNCT03072589Updated Jun 4, 2020

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

A Phase 1 interventional study of Regadenoson infusion in Lung Transplant, sponsored by Christine Lau, MD. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Christine Lau, MD · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
21
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Lung Transplant
03

In context

Lead sponsor

This is the only study on the registry with Christine Lau, MD as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
21 participants (estimated)

Study arms

  • Experimental
    Regadenoson infusion

    Dose escalation of Regadenoson infusion

    Drug: Regadenoson infusion

Interventions

  • DrugRegadenoson infusion

    Dose escalation of Regadenoson when given as an infusion

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What researchers measure

Primary outcomes

  1. Patient tolerability of assigned dose and duration

    Absence of a dose-limiting toxicity

    Time frame: Day 7

Secondary outcomes

  1. Activation of iNKT cells

    Activation of iNKT cells

    Time frame: 24 hours

  2. Clinical Pulmonary Graft Dysfunction (PGD) score

    Evaluate for ischemia reperfusion injury

    Time frame: 72 hours

  3. Inflammatory Cytokines in blood and bronchioalveolar lavage

    Inflammatory Cytokines in blood and bronchioalveolar lavage

    Time frame: 24 hours

07

Study locations

1 of 2 sites recruiting
  • University of Maryland
    Baltimore, Maryland 21201, United States
    Recruiting
  • University of Virginia
    Charlottesville, Virginia 22908, United States
    Active, not recruiting
08

References and documents

Publications

  • Lau CL, Beller JP, Boys JA, Zhao Y, Phillips J, Cosner M, Conaway MR, Petroni G, Charles EJ, Mehaffey JH, Mannem HC, Kron IL, Krupnick AS, Linden J. Adenosine A2A receptor agonist (regadenoson) in human lung transplantation. J Heart Lung Transplant. 2020 Jun;39(6):563-570. doi: 10.1016/j.healun.2020.02.003. Epub 2020 Feb 13. PubMed 32503727 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03072589
Lead sponsor
Christine Lau, MD
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Christine Lau, MD (Surgeon-in-Chief, Department of Surgery, University of Virginia) — Sponsor-investigator
First posted
Mar 7, 2017
Start date
Nov 30, 2017
Primary completion
Aug 1, 2021 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
Jun 4, 2020

Study contacts

Amanda Bartosic, MBA
Contact
ABartosic@som.umaryland.edu
410-328-1641
Jennifer Phillips, RN
Contact
jvp8a@virginia.edu
434-243-5435
Christine Lau, MD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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