NCT03798860

Brief Summary

Single-arm, prospective observational study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

7.3 years

First QC Date

September 26, 2018

Last Update Submit

March 24, 2026

Conditions

Lung TransplantationDonor-specific Anti-human Leukocyte Antigen(HLA) Antibodies

Outcome Measures

Primary Outcomes (1)

  • 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.

    6, 12, 18, 24 months

Secondary Outcomes (2)

  • Graft survival

    1, 3, 5 years

  • Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)

    1, 3, 5 years

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Hanover, Germany

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fabio Ius, Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

January 10, 2019

Study Start

October 1, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

DE(1)