Evaluation of Cell-mediated Immune Response by QuantiFERON Monitor® Assay in Kidney Transplant Recipients

• Conditions: Kidney Transplant Rejection; Kidney Transplant Infection

• Registration Number: NCT03488771
• Lead Sponsor: Clinical Hospital Merkur

Brief Summary

All kidney transplant recipients require immunosuppression, the net level of which is difficult to assess. Current practice in assessing immune reactivity is to monitor levels of some immunosuppressive drugs. QuantiFERON Monitor® (QFM) is an in vitro diagnostic test that detects interferon-γ (IFN-γ) release in peripheral blood. Its clinical utility in assessment of the net state of immunosuppression in kidney transplant recipients has not been well studied. The aim of our study is to evaluate the discriminating value of QFM testing results for infection and rejection in a single-centre cohort of kidney transplant recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-05
• Study First Submitted: 2018-03-22
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-04
• Last Update Submitted: 2018-04-04
• Study First Posted: 2018-04-05
• Last Update Posted: 2018-04-05
• Primary Completion: 2018-06-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infection	throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)	Interferon gamma level in patients with infection

Secondary Outcome Measures

Name	Time	Method
Rejection	throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)	Interferon gamma levels in patients with rejection

Trial Locations

Locations (1)

Clinical Hospital Merkur; 🇭🇷 Zagreb, HR, Croatia