NCT03072589

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

3.7 years

First QC Date

March 1, 2017

Last Update Submit

June 3, 2020

Conditions

Lung Transplant

Outcome Measures

Primary Outcomes (1)

  • Patient tolerability of assigned dose and duration

    Absence of a dose-limiting toxicity

    Day 7

Secondary Outcomes (3)

  • Activation of iNKT cells

    24 hours

  • Clinical Pulmonary Graft Dysfunction (PGD) score

    72 hours

  • Inflammatory Cytokines in blood and bronchioalveolar lavage

    24 hours

Study Arms (1)

Regadenoson infusion

EXPERIMENTAL

Dose escalation of Regadenoson infusion

Drug: Regadenoson infusion

Interventions

Regadenoson infusionDRUG

Dose escalation of Regadenoson when given as an infusion

Regadenoson infusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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.

    PMID: 32503727DERIVED

Study Officials

  • Christine Lau, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Bartosic, MBA

CONTACT

410-328-1641ABartosic@som.umaryland.edu

Jennifer Phillips, RN

CONTACT

434-243-5435jvp8a@virginia.edu

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose escalation study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Surgeon-in-Chief, Department of Surgery

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 7, 2017

Study Start

November 30, 2017

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)