Lung TransplantationNCT03798860
Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation
An observational study of Lung Transplantation and Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies, run by Hannover Medical School at 1 site in Germany.
Trial summary
Single-arm, prospective observational study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplantation, Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies
- What is being tested?
- blood samples
- How many people
- 340 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2018to 31 Dec 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients after lung transplantation with detection of donor-specific antibodies
Who may be able to join
- all patients after lung transplantation with detection of donor-specific antibodies
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
Hanover
About this study
Official title: Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation
Single-arm, prospective observational study
Read the detailed description
This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.
- Being tested
- blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesDiagnostic test
For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor-specific Antibodies Clearance
The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.
Measured: 6, 12, 18, 24 months
Secondary outcomes (2)
Graft survival
Graft survival is defined as freedom from mortality and re-transplantation
Measured: 1, 3, 5 years
Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)
Measured: 1, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Ius, Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798860
- Sponsor's protocol ID
- DSA-2018
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2018
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation
- ClinicalTrials.gov ID
- NCT03798860
- Acronym / sponsor ID
- DSA-2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Jan 2019 (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.
Single-arm, prospective observational study
Detailed description
This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients after lung transplantation with detection of donor-specific antibodies
Key inclusion criteria (1 listed)
- all patients after lung transplantation with detection of donor-specific antibodies
Key exclusion criteria (1 listed)
- none
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 samplesFor performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein. | Diagnostic test | – |
Primary outcome
Donor-specific Antibodies Clearance
Time frame: 6, 12, 18, 24 months
The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.
2 secondary outcomes
Graft survival
Time frame: 1, 3, 5 years
Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)
Time frame: 1, 3, 5 years
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 25 Mar 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. This study is not recruiting at the moment.
Fabio Ius, Dr. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies, run by Hannover Medical School at 1 site in Germany.
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 1 inclusion and 1 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 25 Mar 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 Germany. 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?
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?
Donor-specific Antibodies Clearance (time frame: 6, 12, 18, 24 months). 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 25 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.