Lung TransplantPhase 1NCT03072589
Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation
A Phase 1 study testing Regadenoson infusion in people with Lung Transplant, run by Christine Lau, MD at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Regadenoson infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2017to 1 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Amanda Bartosic, MBA, 410-328-1641, ABartosic@som.umaryland.edu
Christine Lau, MD
- Active, not recruiting
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Phase 1 Open Label Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation
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.
- Conditions
- Lung Transplant
- Being tested
- Regadenoson infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regadenoson infusionDrug
Dose escalation of Regadenoson when given as an infusion
| Study group | Role | What they receive |
|---|---|---|
| Regadenoson infusion | Experimental | Dose escalation of Regadenoson infusion Receives: Drug: Regadenoson infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient tolerability of assigned dose and duration
Absence of a dose-limiting toxicity
Measured: Day 7
Secondary outcomes (3)
Activation of iNKT cells
Activation of iNKT cells
Measured: 24 hours
Clinical Pulmonary Graft Dysfunction (PGD) score
Evaluate for ischemia reperfusion injury
Measured: 72 hours
Inflammatory Cytokines in blood and bronchioalveolar lavage
Inflammatory Cytokines in blood and bronchioalveolar lavage
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start30 Nov 2017
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine Lau, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Christine Lau, MD, University of Virginia
- Investigators
- Christine Lau, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072589
- Sponsor's protocol ID
- UVA-LAU-01
- Other IDs
- 1R01HL128492-01A1
- Status last verified
- Jun 2020
- First submitted
- 1 Mar 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation
- ClinicalTrials.gov ID
- NCT03072589
- Acronym / sponsor ID
- UVA-LAU-01
- Conditions
- Lung Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Christine Lau, MDUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Regadenoson infusion | Experimental | Drug: Regadenoson infusionDose escalation of Regadenoson infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regadenoson infusionDose escalation of Regadenoson when given as an infusion | Drug | Regadenoson infusion |
Primary outcome
Patient tolerability of assigned dose and duration
Time frame: Day 7
Absence of a dose-limiting toxicity
3 secondary outcomes
Activation of iNKT cells
Time frame: 24 hours
Clinical Pulmonary Graft Dysfunction (PGD) score
Time frame: 72 hours
Inflammatory Cytokines in blood and bronchioalveolar lavage
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 32503727Lau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Lau, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Regadenoson infusion in people with Lung Transplant, run by Christine Lau, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Bartosic, MBA (410-328-1641, ABartosic@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient tolerability of assigned dose and duration (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.