Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation
Sponsor
Hannover Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT03798860
Collaborator
(none)
70
1
50
1.4
Study Details
Study Description
Brief Summary
Single-arm, prospective observational study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational
Anticipated Enrollment
:
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date
:
Oct 1, 2018
Anticipated Primary Completion Date
:
Jul 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Outcome Measures
Primary Outcome Measures
- Donor-specific Antibodies Clearance [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.
Secondary Outcome Measures
- Graft survival [1, 3, 5 years]
Graft survival is defined as freedom from mortality and re-transplantation
- Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD) [1, 3, 5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- all patients after lung transplantation with detection of donor-specific antibodies
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery | Hannover | Germany |
Sponsors and Collaborators
- Hannover Medical School
Investigators
- Principal Investigator: Fabio Ius, Dr., Hannover Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT03798860
Other Study ID Numbers:
- DSA-2018
First Posted:
Jan 10, 2019
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No