Immune Monitoring after paediatric liver Transplantation - in search for markers of over- and under-immunosuppressio

• Conditions: Z94.4; Liver transplant status

• Registration Number: DRKS00011739
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

In a cohort of 246 children undergoing liver transplantation, survival over the 1rst year after transplantation was excellent at 98%. Rejection rates differ significantly across primary immunosuppresion groups, with children treated with tacrolimus plus steroids having markedly lower rates of T-cell mediated rejection than children treated with tacrolimus monotherapy. Analysis of soluble immune markers revealed distinct immune signatures that become apparent at 2 weeks after transplantation and then stay relatively stable over the course of the first year after transplantation. One of these signatures is associated with a favorable outcome, i.e. freedom of rejection during the first year after transplantation irrespective of clinical predictors of rejection.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Results First Posted: 2019-01-25
• Study Completion: 2021-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

Liver transplantation

Exclusion Criteria

severe comorbidity that prevents compliance with therapy or study investigations

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary target is the change in immune markers (cytokine profiles, chemokine profiles, immune cell populations) in relation to time. To evaluate change in markers over time, a multivariable finite mixture model of trajectories will be used.

Secondary Outcome Measures

Name	Time	Method
Secondary target is the Change in immune markers in relation to clinical course, i.e. the occurence of rejection.