Lung TransplantEarly Phase 1NCT04521569
Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System
A Early Phase 1 study testing Regadenoson in people with Lung Transplant, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of this study is to see if adding a drug called Regadenoson to the EVLP circulation reservoir during perfusion of marginal donor lungs will help increase the likelihood that the donor lungs will become usable for transplantation. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jun 2020to 31 Jul 2024
- Phase
- Early 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
- Donor Lung Inclusion Criteria for EVLP
- At the time of clinical evaluation, the PaO2/FiO2 ≤ 300mm Hg OR
- If the PaO2/FiO2 is > 300mm hg and the donor has any one of more of the following donor risk factors:
- Multiple blood transfusions
- Pulmonary Edema detected via CXR, Bronchoscopy or palpation of the lungs
- Donation after cardiac death donors
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- High risk donor history (example: asphyxia, hanging, drowning)
- Donor lung Inclusion Criteria for Transplant Suitability after EVLP
- Delta PaO2 greater than 350 mmhg (measured with an FiO2 set at 1.0) at two consecutive time periods at 2, 3, or 4 hours of EVLP.
- Stability or improvement of other lung function parameters during EVLP perfusion, such as PVR, compliance, or airway pressures.
- Lungs clinically suitable for transplantation (e.g. without signs of significant contusions, edema, or secretion) in the opinion of the surgical investigator(s).
- Participant Inclusion Criteria
- Subjects must be undergoing a single or bilateral lung transplantation for end-stage lung disease and thus meet all criteria to be listed. Single lungs are only allowable when initially placed as bilaterally block on EVLP circuit.
- Male or female subject, 18 -75 years of age.
- Subject agrees to accept EVLP perfused lungs.
- Subjects must sign a study specific informed consent prior to study entry.
Who cannot join
- Donor Lung Exclusion Criteria for EVLP
- Donor lung has significant pneumonia as defined by positive bacterial growth in blood culture (not related to other source of infection) or persistent purulent, un-clearable secretions on bronchoscopy OR as determined by the investigator.
- Donor has aspirated gastric contents into the lung. Donor lung has significant mechanical lung injury or trauma.
- Donor lung has active infections disease, such as HIV, Hepatitis B or C, HTLV or syphilis.
- Donor lung must not be split and perfused as single lung on EVLP circuit.
- Donor Lung Exclusion Criteria for Transplant Suitability after EVLP (All of the below must be negative)
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- Delta PaO2 less than 350 mmHg (measured with FiO2 set at 1.0) at two consecutive time periods at 2, 3 or 4 hours of ex Vivo perfusion.
- > 10% functional deterioration of other lung parameters during EVLP such as PVR, compliance or airway pressures.
- Participant Exclusion Criteria
- Subject requires preoperative extracorporeal membrane oxygenation (ECMO).
- Subjects who are receiving or have received within 30 days any other investigational agents.
- Subjects with Burkolderia cepacia.
- Subjects who have had a previous lung transplant.
- Subjects who have an uncontrolled concurrent illness including, but not limited to an ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements per investigator discretion.
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Cleveland Clinic
Cleveland, Ohio, 44195 |
About this study
Official title: A Randomized, Blinded, Multi-site, Pilot Study to Evaluate Adenosine 2A Receptor Agonist (REGADENOSON) in the Rehabilitation of Marginal Donor Lungs.
The purpose of this study is to see if adding a drug called Regadenoson to the EVLP circulation reservoir during perfusion of marginal donor lungs will help increase the likelihood that the donor lungs will become usable for transplantation.
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.
Molecule called Adenosine 2A receptor (A2AR) have been studied in animals with IRI for many years. Some of these studies suggest that with the use of A2AR agonist, the chance of IRI may be lowered or prevented. Regadenoson is a selective A2AR agonist.
- Conditions
- Lung Transplant
- Being tested
- Regadenoson, Placebo
- Keywords
- EVLP, Lung Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
Also called Lexiscan
If the donor lungs are randomized the experimental arm, the administration of Regadenoson will be performed at each study site by a qualified medical professional. The donor lungs will be perfused with Regadenoson at a dosage of 1.44 microgram/kg/min (based on donor's weight) for a minimum of three hours and maximum of four hours, using a pediatric syringe pump into the EVLP circuit (XVIVO Perfusion System). The infusion will begin within 10 minutes of the start of the EVLP procedure. Once the EVLP is complete the lungs are re-flushed with Perfadex solution (removing the Steen™ solution and Regadenoson; standard for EVLP).
PlaceboDrug
Also called Steen solution
If the donor lungs are randomized to the Steen solution arm, the donor lungs will be perfused with placebo at a rate equivalent to the dosage of Regadenoson (1.44 microgram/kg/min), for a minimum of three hours and maximum of four hours, using the same pediatric syringe pump. The infusion will begin within 10 minutes of the start of the EVLP procedure.
| Study group | Role | What they receive |
|---|---|---|
| EVLP with Regadenoson | Experimental | Following the routine retrieval procedure of the lungs, they will be placed on the EVLP circuit (XVIVO Perfusion System) and infused with the study drug, Regadenoson. Receives: Drug: Regadenoson |
| EVLP with Steen solution | Placebo comparator | Following the routine retrieval procedure of the lungs, they will be placed on the EVLP circuit (XVIVO Perfusion System) and infused with the same volume of Steen solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Rehabilitation
The primary endpoint is rehabilitation (yes, no) for marginal donor lungs that undergo ex-vivo perfusion using a "lung box" as assessed by the transplant surgeon and utilizing the "Toronto Method" clinical protocol. Rate of rehabilitation is defined as the proportion of sets of lungs that underwent EVLP with/without Regadenoson treatment and are determined to be eligible for implant.
Measured: 30 days
Secondary outcomes (5)
Primary Lung Graft Dysfunction (PGD) Score
Primary graft dysfunction (PGD) is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation. A score of Score 0 means no PGD and 1-3 increasingly more severe. 3 is so severe requires ECMO support.
Measured: 72 hours
Intensive care unit length of stay
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Measured: 8 weeks
Using of ECMO
How often the patient will use ECMO due to lung infection after lung transplantation
Measured: 1 week
Duration on ventilator post-Operative
Will measure how long the patient use ventilator post-operation.
Measured: 1 month
12-month survival
Patient survival 360 days after lung transplantation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start22 Jun 2020
- Primary completion23 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to the EVLP with placebo or EVLP with Regadenoson groups will be performed in a 1:2 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christine Lau, University of Maryland, Baltimore
- Investigators
- Christine Lau, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521569
- Sponsor's protocol ID
- UVA-LAU-02
- Other IDs
- 5R01HL128492-04
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2020
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Multi-site, Pilot Study to Evaluate Adenosine 2A Receptor Agonist (REGADENOSON) in the Rehabilitation of Marginal Donor Lungs.
- ClinicalTrials.gov ID
- NCT04521569
- Acronym / sponsor ID
- UVA-LAU-02
- Conditions
- Lung Transplant
- Keywords
- EVLP, Lung Transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 20 Aug 2020 (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.
The purpose of this study is to see if adding a drug called Regadenoson to the EVLP circulation reservoir during perfusion of marginal donor lungs will help increase the likelihood that the donor lungs will become usable for transplantation.
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.
Molecule called Adenosine 2A receptor (A2AR) have been studied in animals with IRI for many years. Some of these studies suggest that with the use of A2AR agonist, the chance of IRI may be lowered or prevented. Regadenoson is a selective A2AR agonist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization to the EVLP with placebo or EVLP with Regadenoson groups will be performed in a 1:2 ratio.
| Arm | Type | Receives |
|---|---|---|
| EVLP with Regadenoson | Experimental | Drug: RegadenosonFollowing the routine retrieval procedure of the lungs, they will be placed on the EVLP circuit (XVIVO Perfusion System) and infused with the study drug, Regadenoson. |
| EVLP with Steen solution | Placebo comparator | Drug: PlaceboFollowing the routine retrieval procedure of the lungs, they will be placed on the EVLP circuit (XVIVO Perfusion System) and infused with the same volume of Steen solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Donor Lung Inclusion Criteria for EVLP
- At the time of clinical evaluation, the PaO2/FiO2 ≤ 300mm Hg OR
- If the PaO2/FiO2 is > 300mm hg and the donor has any one of more of the following donor risk factors:
- Donor lung Inclusion Criteria for Transplant Suitability after EVLP
- Delta PaO2 greater than 350 mmhg (measured with an FiO2 set at 1.0) at two consecutive time periods at 2, 3, or 4 hours of EVLP.
Key exclusion criteria (15 listed)
- Donor Lung Exclusion Criteria for EVLP
- Donor lung has significant pneumonia as defined by positive bacterial growth in blood culture (not related to other source of infection) or persistent purulent, un-clearable secretions on bronchoscopy OR as determined by the investigator.
- Donor has aspirated gastric contents into the lung. Donor lung has significant mechanical lung injury or trauma.
- Donor lung has active infections disease, such as HIV, Hepatitis B or C, HTLV or syphilis.
- Donor lung must not be split and perfused as single lung on EVLP circuit.
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 |
|---|---|---|
| RegadenosonAlso: LexiscanIf the donor lungs are randomized the experimental arm, the administration of Regadenoson will be performed at each study site by a qualified medical professional. The donor lungs will be perfused with Regadenoson at a dosage of 1.44 microgram/kg/min (based on donor's weight) for a minimum of three hours and maximum of four hours, using a pediatric syringe pump into the EVLP circuit (XVIVO Perfusion System). The infusion will begin within 10 minutes of the start of the EVLP procedure. Once the EVLP is complete the lungs are re-flushed with Perfadex solution (removing the Steen™ solution and Regadenoson; standard for EVLP). | Drug | EVLP with Regadenoson |
| PlaceboAlso: Steen solutionIf the donor lungs are randomized to the Steen solution arm, the donor lungs will be perfused with placebo at a rate equivalent to the dosage of Regadenoson (1.44 microgram/kg/min), for a minimum of three hours and maximum of four hours, using the same pediatric syringe pump. The infusion will begin within 10 minutes of the start of the EVLP procedure. | Drug | EVLP with Steen solution |
Primary outcome
Lung Rehabilitation
Time frame: 30 days
The primary endpoint is rehabilitation (yes, no) for marginal donor lungs that undergo ex-vivo perfusion using a "lung box" as assessed by the transplant surgeon and utilizing the "Toronto Method" clinical protocol. Rate of rehabilitation is defined as the proportion of sets of lungs that underwent EVLP with/without Regadenoson treatment and are determined to be eligible for implant.
5 secondary outcomes
Primary Lung Graft Dysfunction (PGD) Score
Time frame: 72 hours
Intensive care unit length of stay
Time frame: 8 weeks
Using of ECMO
Time frame: 1 week
Duration on ventilator post-Operative
Time frame: 1 month
12-month survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- 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 Early Phase 1 study testing Regadenoson in people with Lung Transplant, run by University of Maryland, Baltimore 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 16 inclusion and 15 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: finished, as of the sponsor's last update on 5 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Rehabilitation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2024.