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Active, not recruiting Observational

Immune Function as Predictor of Infectious Complications and Clinical Outcome in Patients Undergoing Solid Organ Transplantation

NCT03847285 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2018-04-01
Last updated
2026-08-12

Condition(s) studied

Transplant

Investigational drug(s) / intervention(s)

solid organ transplantation

solid organ transplantation: solid organ transplantation: kidney, heart, pancreas, lung and liver transplantation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Infection — one year
    Infections (viral, bacterial or fungal) within 1 year after the transplantation
  • graft rejection — one year
    Graft rejection within 1 year after the transplantation. Rejections will be defined by pathologist and clinician.

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03847285 on ClinicalTrials.gov ↗ ← All trials in Denmark