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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
Sponsor:
Information provided by (Responsible Party):
Susanne Dam Nielsen, MD, DMSc, Rigshospitalet, Denmark

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Intervention Details:
  • Other: solid organ transplantation
    solid organ transplantation: kidney, heart, pancreas, lung and liver transplantation


Primary Outcome Measures :
  1. Infection [ Time Frame: one year ]
    Infections (viral, bacterial or fungal) within 1 year after the transplantation

  2. graft rejection [ Time Frame: one year ]
    Graft rejection within 1 year after the transplantation. Rejections will be defined by pathologist and clinician.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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
whole blood and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants must have a planned kidney, heart, lung, liver or pancreas transplant or be on the waiting list for a heart, lung, liver or pancreas-transplantation at Rigshospitalet, Denmark
Criteria

Inclusion Criteria:

  • To be eligible for the study the participant must be a minimum of 18 years of age, participate in the PERSIMUNE biobank, have a planned kidney, heart, lung, liver or pancreas transplant or be on the waiting list for a heart, lung, liver or pancreas transplant and be able to sufficiently understand oral and written study information in Danish or English to provide an informed consent. Study participation is strictly voluntary

Exclusion Criteria:

  • not meeting inclusion criteria

Information from the National Library of Medicine

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


Contacts
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Contact: Susanne Dam Nielsen, DMSc +4535457764 sdn@dadlnet.dk
Contact: Dina Leth Møller, MD +4535455907 dina.leth.moeller@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Susanne Dam Nielsen, DMSc    +4535457764    sdn@dadlnet.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Susanne Dam Nielsen, DMSc Rigshospitalet, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susanne Dam Nielsen, MD, DMSc, Principal investigator, clinical professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03847285    
Other Study ID Numbers: sponsor - rigshospitalet
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susanne Dam Nielsen, MD, DMSc, Rigshospitalet, Denmark:
Transplant
Infection
rejection
immunology
Additional relevant MeSH terms:
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Communicable Diseases
Infection