Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation

March 1, 2023 updated by: Hannover Medical School

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hannover, Germany
        • Recruiting
        • Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
        • Contact:
        • Principal Investigator:
          • Fabio Ius, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients after lung transplantation with detection of donor-specific antibodies

Description

Inclusion Criteria:

  • all patients after lung transplantation with detection of donor-specific antibodies

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6, 12, 18, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft survival
Time Frame: 1, 3, 5 years
Graft survival is defined as freedom from mortality and re-transplantation
1, 3, 5 years
Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)
Time Frame: 1, 3, 5 years
1, 3, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Fabio Ius, Dr., Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DSA-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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