Lung TransplantNCT05581745
A2 to O Lung Transplants
A study testing Blood group A2 donor to blood group O recipient lung transplant surgery in people with Lung Transplant and ABO Incompatibility, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, ABO Incompatibility
- What is being tested?
- Blood group A2 donor to blood group O recipient lung transplant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2022to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first lung transplant
- blood group O recipient
- low pre-operative anti-A antibody titers
- consent to study participation
Who cannot join
- re-transplant
- multiorgan transplant
- positive virtual crossmatch at time of transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Sharaniyaa Balachandran, 416-340-4800 ext. 6549, sharaniyaa.balachandran@uhn.ca
Shaf Keshavjee, MD MSc
About this study
Official title: Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation
Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Since blood group O lung transplant candidates tend to have longer wait times and a higher waitlist mortality compared to other blood groups, we propose to conduct a prospective study of lung transplantation from blood group A2 donors to eligible blood group O recipients in an effort to increase the available donor pool. The aim of this study is to determine both the feasibility and safety of this specific type of ABO-incompatible lung transplant, and the impact of this practice on reducing transplant wait times among blood group O lung transplant candidates. This would represent the first prospective study of ABO-incompatible lung transplants worldwide.
- Conditions
- Lung Transplant, ABO Incompatibility
- Being tested
- Blood group A2 donor to blood group O recipient lung transplant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood group A2 donor to blood group O recipient lung transplant surgeryProcedure or surgery
Suitable blood group A2 donor lung transplant to a consented blood group O recipient who has acceptably low levels of anti-A antibody titres and a negative virtual cross-match at time of transplant
| Study group | Role | What they receive |
|---|---|---|
| A2 donor transplant to O recipient | Experimental | Not described Receives: Procedure: Blood group A2 donor to blood group O recipient lung transplant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-transplant anti-A antibody titers
Measured: post-op day 5 or day 12
Primary graft dysfunction grade
Measured: post-op day 0, 1, 2, 3
Incidence of hyperacute antibody-mediated rejection
Measured: post-op day 1, 2
C4d positivity on transbronchial biopsy samples
Measured: 1 year
Incidence and severity of acute cellular rejection
Measured: 1 year
Bleeding
Measured: post-op day 1-7
Infection
Measured: 10 years
Graft function
Measured: 10 years
Incidence of malignancy
Measured: 10 years
Chronic lung allograft dysfunction
Measured: 10 years
Time to death or re-transplantation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start14 Jul 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2033 (estimated)
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 Health Network, TorontoThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaf Keshavjee, MD MSc FRCSC FACS, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581745
- Sponsor's protocol ID
- 21-5005
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation
- ClinicalTrials.gov ID
- NCT05581745
- Acronym / sponsor ID
- 21-5005
- Conditions
- Lung Transplant, ABO Incompatibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 14 Oct 2022 (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.
Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Since blood group O lung transplant candidates tend to have longer wait times and a higher waitlist mortality compared to other blood groups, we propose to conduct a prospective study of lung transplantation from blood group A2 donors to eligible blood group O recipients in an effort to increase the available donor pool. The aim of this study is to determine both the feasibility and safety of this specific type of ABO-incompatible lung transplant, and the impact of this practice on reducing transplant wait times among blood group O lung transplant candidates. This would represent the first prospective study of ABO-incompatible lung transplants worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A2 donor transplant to O recipient | Experimental | Procedure: Blood group A2 donor to blood group O recipient lung transplant surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first lung transplant
- blood group O recipient
- low pre-operative anti-A antibody titers
- consent to study participation
Key exclusion criteria (3 listed)
- re-transplant
- multiorgan transplant
- positive virtual crossmatch at time of transplant
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 |
|---|---|---|
| Blood group A2 donor to blood group O recipient lung transplant surgerySuitable blood group A2 donor lung transplant to a consented blood group O recipient who has acceptably low levels of anti-A antibody titres and a negative virtual cross-match at time of transplant | Procedure or surgery | A2 donor transplant to O recipient |
Primary outcome
Post-transplant anti-A antibody titers
Time frame: post-op day 5 or day 12
Primary graft dysfunction grade
Time frame: post-op day 0, 1, 2, 3
Incidence of hyperacute antibody-mediated rejection
Time frame: post-op day 1, 2
C4d positivity on transbronchial biopsy samples
Time frame: 1 year
Incidence and severity of acute cellular rejection
Time frame: 1 year
Bleeding
Time frame: post-op day 1-7
Infection
Time frame: 10 years
Graft function
Time frame: 10 years
Incidence of malignancy
Time frame: 10 years
Chronic lung allograft dysfunction
Time frame: 10 years
Time to death or re-transplantation
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
Shaf Keshavjee, MD MSc FRCSC FACS principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood group A2 donor to blood group O recipient lung transplant surgery in people with Lung Transplant and ABO Incompatibility, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharaniyaa Balachandran (416-340-4800 ext. 6549, sharaniyaa.balachandran@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-transplant anti-A antibody titers (time frame: post-op day 5 or day 12). The study lists 11 primary outcomes in all. 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 29 Sep 2026.