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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL128492-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regadenoson infusion | Experimental | Dose escalation of Regadenoson infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson infusion | Drug | Dose escalation of Regadenoson when given as an infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient tolerability of assigned dose and duration | Absence of a dose-limiting toxicity | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of iNKT cells | Activation of iNKT cells | 24 hours |
| Clinical Pulmonary Graft Dysfunction (PGD) score | Evaluate for ischemia reperfusion injury |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Bartosic, MBA | Contact | 410-328-1641 | ABartosic@som.umaryland.edu | |
| Jennifer Phillips, RN | Contact | 434-243-5435 | jvp8a@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christine Lau, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32503727 | Derived | 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. |
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Dose escalation study
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| 72 hours |
| Inflammatory Cytokines in blood and bronchioalveolar lavage | Inflammatory Cytokines in blood and bronchioalveolar lavage | 24 hours |
| University of Virginia | Active, not recruiting | Charlottesville | Virginia | 22908 | United States |