Immune Function as Predictor of Infectious Complications and Clinical Outcome in Patients Undergoing Solid Organ Transplantation (Immune-Mo)
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|ClinicalTrials.gov Identifier: NCT03847285|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : October 5, 2020
At Rigshospitalet, Denmark, we will examine the immune function of solid organ transplant recipients before and at several timepoints after transplantation as well as the clinical outcome, especially the risk of infections complications and graft rejections.
The immune function will be assessed with a complete immunological profiling consisting of immune phenotype (flow cytometry), immune function (TruCulture®) and circulating biomarkers.
The study aims to generate prediction models of patients at excess risk of poor clinical outcome, with the ultimate intent to propose personalized immunosuppressive regimes to be tested in future randomized clinical trials.
|Condition or disease||Intervention/treatment|
|Transplant||Other: solid organ transplantation|
Background: Solid organ transplantation (SOT) is an increasingly used life-saving treatment for end-stage organ failure. Organ rejection and infections are the main complication to SOT and the balance of immunosuppression is of major importance to prevent these complications. However, to date the only mode to monitor treatment is by assessing drug concentrations, which has low correlation with the clinical outcome and does not represent the net state of immunosuppression.
Methods: Prospectively the investigators plan to enroll 600 adult patients on the waiting list for SOT or with a planned transplantation at Rigshospitalet, Denmark. Prior to transplantation and on different time points up to two years post-transplantation we will perform a complete immunological profile. This profile will consist of classical descriptive immune phenotyping (flowcytometry), circulating biomarkers and the functional assay TruCulture®. In TruCulture® whole blood is stimulated with stimulants imitating bacterial, viral and fungal infections, where after a panel of selected cytokines is quantified.
Clinical data from electronic health records will be obtained retrospectively from the PERSIMUNE data repository. These data are generated as part of routine care and include vital signs, biochemistry-, microbiological-, pathological-results as well as data about medication, demographics, diagnoses, hospital contacts, surgical procedures and mortality.
Discussion: This will be the first large scale study to determine several aspects of immune function and perform a complete immunological profiling in SOT recipients. It is expected that this new knowledge will provide information to generate prediction models identifying patients at increased risk of infection and/or rejection. If the study is successful, the investigators will subsequently use the generated prediction models to propose personalized immunosuppressive regimens to be tested in future randomized controlled trials.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Immune Function as Predictor of Infectious Complications and Clinical Outcome in Patients Undergoing Solid Organ Transplantation: A Prospective Non-interventional Observational Trial|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||April 1, 2025|
- Other: solid organ transplantation
solid organ transplantation: kidney, heart, pancreas, lung and liver transplantation
- Infection [ Time Frame: one year ]Infections (viral, bacterial or fungal) within 1 year after the transplantation
- graft rejection [ Time Frame: one year ]Graft rejection within 1 year after the transplantation. Rejections will be defined by pathologist and clinician.
- combined endpoints at 28 days post transplantation [ Time Frame: 28 days ]Combined endpoint of infections (viral, bacterial or fungal) or graft rejection within 28 days
- combined endpoints at 90 days post transplantation [ Time Frame: 90 days ]Combined endpoint of infections (viral, bacterial or fungal) or graft rejection within 90 days
- combined endpoints at 2 years post transplantation [ Time Frame: 2 years ]Combined endpoint of infections (viral, bacterial or fungal) or graft rejection within 2 years
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847285
|Contact: Susanne Dam Nielsen, DMScfirstname.lastname@example.org|
|Contact: Dina Leth Møller, MDemail@example.com|
|Copenhagen, Denmark, 2100|
|Contact: Susanne Dam Nielsen, DMSc +4535457764 firstname.lastname@example.org|
|Principal Investigator:||Susanne Dam Nielsen, DMSc||Rigshospitalet, Denmark|